THE OFFICIAL PATIENT’S SOURCEBOOK
on
J AMES N. P ARKER , M.D. AND P HILIP M. P ARKER , P H .D., E DITORS
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ICON Health Publications ICON Group International, Inc. 4370 La Jolla Village Drive, 4th Floor San Diego, CA 92122 USA Copyright Ó2002 by ICON Group International, Inc. Copyright Ó2002 by ICON Group International, Inc. All rights reserved. This book is protected by copyright. No part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without written permission from the publisher. Printed in the United States of America. Last digit indicates print number: 10 9 8 7 6 4 5 3 2 1
Publisher, Health Care: Tiffany LaRochelle Editor(s): James Parker, M.D., Philip Parker, Ph.D. Publisher’s note: The ideas, procedures, and suggestions contained in this book are not intended as a substitute for consultation with your physician. All matters regarding your health require medical supervision. As new medical or scientific information becomes available from academic and clinical research, recommended treatments and drug therapies may undergo changes. The authors, editors, and publisher have attempted to make the information in this book up to date and accurate in accord with accepted standards at the time of publication. The authors, editors, and publisher are not responsible for errors or omissions or for consequences from application of the book, and make no warranty, expressed or implied, in regard to the contents of this book. Any practice described in this book should be applied by the reader in accordance with professional standards of care used in regard to the unique circumstances that may apply in each situation, in close consultation with a qualified physician. The reader is advised to always check product information (package inserts) for changes and new information regarding dose and contraindications before taking any drug or pharmacological product. Caution is especially urged when using new or infrequently ordered drugs, herbal remedies, vitamins and supplements, alternative therapies, complementary therapies and medicines, and integrative medical treatments. Cataloging-in-Publication Data Parker, James N., 1961Parker, Philip M., 1960The Official Patient’s Sourcebook on Colon Cancer: A Revised and Updated Directory for the Internet Age/James N. Parker and Philip M. Parker, editors p. cm. Includes bibliographical references, glossary and index. ISBN: 0-597-83350-8 1. Colon Cancer-Popular works. I. Title.
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Disclaimer This publication is not intended to be used for the diagnosis or treatment of a health problem or as a substitute for consultation with licensed medical professionals. It is sold with the understanding that the publisher, editors, and authors are not engaging in the rendering of medical, psychological, financial, legal, or other professional services. References to any entity, product, service, or source of information that may be contained in this publication should not be considered an endorsement, either direct or implied, by the publisher, editors or authors. ICON Group International, Inc., the editors, or the authors are not responsible for the content of any Web pages nor publications referenced in this publication.
Copyright Notice If a physician wishes to copy limited passages from this sourcebook for patient use, this right is automatically granted without written permission from ICON Group International, Inc. (ICON Group). However, all of ICON Group publications are copyrighted. With exception to the above, copying our publications in whole or in part, for whatever reason, is a violation of copyright laws and can lead to penalties and fines. Should you want to copy tables, graphs or other materials, please contact us to request permission (e-mail:
[email protected]). ICON Group often grants permission for very limited reproduction of our publications for internal use, press releases, and academic research. Such reproduction requires confirmed permission from ICON Group International Inc. The disclaimer above must accompany all reproductions, in whole or in part, of this sourcebook.
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Dedication To the healthcare professionals dedicating their time and efforts to the study of colon cancer.
Acknowledgements The collective knowledge generated from academic and applied research summarized in various references has been critical in the creation of this sourcebook which is best viewed as a comprehensive compilation and collection of information prepared by various official agencies which directly or indirectly are dedicated to colon cancer. All of the Official Patient’s Sourcebooks draw from various agencies and institutions associated with the United States Department of Health and Human Services, and in particular, the Office of the Secretary of Health and Human Services (OS), the Administration for Children and Families (ACF), the Administration on Aging (AOA), the Agency for Healthcare Research and Quality (AHRQ), the Agency for Toxic Substances and Disease Registry (ATSDR), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Healthcare Financing Administration (HCFA), the Health Resources and Services Administration (HRSA), the Indian Health Service (IHS), the institutions of the National Institutes of Health (NIH), the Program Support Center (PSC), and the Substance Abuse and Mental Health Services Administration (SAMHSA). In addition to these sources, information gathered from the National Library of Medicine, the United States Patent Office, the European Union, and their related organizations has been invaluable in the creation of this sourcebook. Some of the work represented was financially supported by the Research and Development Committee at INSEAD. This support is gratefully acknowledged. Finally, special thanks are owed to Tiffany LaRochelle for her excellent editorial support.
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About the Editors James N. Parker, M.D. Dr. James N. Parker received his Bachelor of Science degree in Psychobiology from the University of California, Riverside and his M.D. from the University of California, San Diego. In addition to authoring numerous research publications, he has lectured at various academic institutions. Dr. Parker is the medical editor for the Official Patient’s Sourcebook series published by ICON Health Publications.
Philip M. Parker, Ph.D. Philip M. Parker is the Eli Lilly Chair Professor of Innovation, Business and Society at INSEAD (Fontainebleau, France and Singapore). Dr. Parker has also been Professor at the University of California, San Diego and has taught courses at Harvard University, the Hong Kong University of Science and Technology, the Massachusetts Institute of Technology, Stanford University, and UCLA. Dr. Parker is the associate editor for the Official Patient’s Sourcebook series published by ICON Health Publications.
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About ICON Health Publications In addition to colon cancer, Official Patient’s Sourcebooks are available for the following related topics: ·
The Official Patient's Sourcebook on Adult Primary Liver Cancer
·
The Official Patient's Sourcebook on Anal Cancer
·
The Official Patient's Sourcebook on Esophageal Cancer
·
The Official Patient's Sourcebook on Extrahepatic Bile Duct Cancer
·
The Official Patient's Sourcebook on Gallbladder Cancer
·
The Official Patient's Sourcebook on Gastric Cancer
·
The Official Patient's Sourcebook on Gastrointestinal Carcinoid Tumor
·
The Official Patient's Sourcebook on Pancreatic Cancer
·
The Official Patient's Sourcebook on Rectal Cancer
·
The Official Patient's Sourcebook on Small Intestine Cancer
To discover more about ICON Health Publications, simply check with your preferred online booksellers, including Barnes & Noble.com and Amazon.com which currently carry all of our titles. Or, feel free to contact us directly for bulk purchases or institutional discounts: ICON Group International, Inc. 4370 La Jolla Village Drive, Fourth Floor San Diego, CA 92122 USA Fax: 858-546-4341 Web site: www.icongrouponline.com/health
Contents vii
Table of Contents INTRODUCTION...................................................................................... 1
Overview............................................................................................................... 1 Organization......................................................................................................... 3 Scope ..................................................................................................................... 3 Moving Forward................................................................................................... 4
PART I: THE ESSENTIALS ................................................. 7 CHAPTER 1. THE ESSENTIALS ON COLON CANCER: GUIDELINES ....... 9
Overview............................................................................................................... 9 What Is Colon Cancer?....................................................................................... 11 Risk Factors ........................................................................................................ 11 Symptoms ........................................................................................................... 12 Diagnosis ............................................................................................................ 12 Prognosis ............................................................................................................ 13 Staging................................................................................................................ 13 Treatment Options ............................................................................................. 15 Treatments Being Tested in Clinical Trials........................................................ 16 Treatment Options by Stage............................................................................... 17 Treatment Options for Recurrent Colon Cancer................................................ 19 To Learn More .................................................................................................... 19 About PDQ......................................................................................................... 20 More Guideline Sources ..................................................................................... 21 Vocabulary Builder............................................................................................. 30
CHAPTER 2. SEEKING GUIDANCE ....................................................... 35
Overview............................................................................................................. 35 Associations and Colon Cancer .......................................................................... 35 Finding More Associations................................................................................. 45 Cancer Support Groups...................................................................................... 47 The Cancer Information Service ......................................................................... 49 Finding Cancer Resources in Your Community................................................ 51 Finding Doctors Who Specialize in Cancer Care ............................................... 55 Selecting Your Doctor ........................................................................................ 57 Working with Your Doctor ................................................................................ 59 Finding a Cancer Treatment Facility ................................................................. 60 Additional Cancer Support Information ............................................................ 62 Vocabulary Builder............................................................................................. 62
CHAPTER 3. CLINICAL TRIALS AND COLON CANCER........................ 65
Overview............................................................................................................. 65 Recent Trials on Colon Cancer........................................................................... 68 Benefits and Risks............................................................................................... 97 Clinical Trials and Insurance Coverage ........................................................... 100
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Clinical Trials and Medicare Coverage ............................................................ 103 Increasing the Likelihood of Insurance Coverage for Trials ............................. 104 If Your Insurance Claim Is Denied after the Trial Has Begun ........................ 106 Government Initiatives to Expand Insurance Coverage for Trials .................. 109 Keeping Current on Clinical Trials.................................................................. 110 General References............................................................................................ 111 Vocabulary Builder........................................................................................... 112
PART II: ADDITIONAL RESOURCES AND ADVANCED MATERIAL................................................ 117 CHAPTER 4. STUDIES ON COLON CANCER ....................................... 119
Overview........................................................................................................... 119 The Combined Health Information Database ................................................... 119 Federally Funded Research on Colon Cancer ................................................... 130 E-Journals: PubMed Central ............................................................................ 135 The National Library of Medicine: PubMed .................................................... 140 Vocabulary Builder........................................................................................... 155
CHAPTER 5. PATENTS ON COLON CANCER ...................................... 163
Overview........................................................................................................... 163 Patents on Colon Cancer .................................................................................. 164 Patent Applications on Colon Cancer .............................................................. 170 Keeping Current ............................................................................................... 177 Vocabulary Builder........................................................................................... 177
CHAPTER 6. BOOKS ON COLON CANCER ......................................... 179
Overview........................................................................................................... 179 Book Summaries: Federal Agencies .................................................................. 179 The National Library of Medicine Book Index ................................................. 181 Chapters on Colon Cancer ................................................................................ 184 General Home References ................................................................................. 192 Vocabulary Builder........................................................................................... 193
CHAPTER 7. MULTIMEDIA ON COLON CANCER............................... 195
Overview........................................................................................................... 195 Video Recordings .............................................................................................. 195 Bibliography: Multimedia on Colon Cancer..................................................... 197 Vocabulary Builder........................................................................................... 200
CHAPTER 8. PERIODICALS AND NEWS ON COLON CANCER............ 203
Overview........................................................................................................... 203 News Services & Press Releases ....................................................................... 203 Newsletters on Colon Cancer ........................................................................... 214 Newsletter Articles ........................................................................................... 215 Academic Periodicals Covering Colon Cancer ................................................. 219 Vocabulary Builder........................................................................................... 221
CHAPTER 9. PHYSICIAN GUIDELINES AND DATABASES ................... 223
Contents
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Overview........................................................................................................... 223 NIH Guidelines................................................................................................. 223 What Is Colon Cancer?..................................................................................... 224 Adjuvant Therapy............................................................................................. 227 Advanced Disease ............................................................................................. 228 Cellular Classification ...................................................................................... 231 Stage Information ............................................................................................. 231 Treatment Option Overview ............................................................................ 233 Recurrent Colon Cancer ................................................................................... 253 NIH Databases.................................................................................................. 262 Other Commercial Databases ........................................................................... 272 The Genome Project and Colon Cancer............................................................ 273 Specialized References....................................................................................... 277 Vocabulary Builder........................................................................................... 278
CHAPTER 10. DISSERTATIONS ON COLON CANCER ......................... 281
Overview........................................................................................................... 281 Dissertations on Colon Cancer......................................................................... 281 Keeping Current ............................................................................................... 283 Vocabulary Builder........................................................................................... 283
PART III. APPENDICES .................................................. 285 APPENDIX A. RESEARCHING YOUR MEDICATIONS.......................... 287
Overview........................................................................................................... 287 Your Medications: The Basics .......................................................................... 288 Learning More about Your Medications .......................................................... 289 Commercial Databases...................................................................................... 291 Drug Development and Approval .................................................................... 292 Understanding the Approval Process for New Cancer Drugs......................... 293 The Role of the Federal Drug Administration (FDA)...................................... 294 Getting Drugs to Patients Who Need Them .................................................... 298 Contraindications and Interactions (Hidden Dangers) ................................... 300 A Final Warning .............................................................................................. 301 General References............................................................................................ 301 Vocabulary Builder........................................................................................... 302
APPENDIX B. RESEARCHING ALTERNATIVE MEDICINE ................... 303
Overview........................................................................................................... 303 What Is CAM? ................................................................................................. 304 What Are the Domains of Alternative Medicine?............................................ 305 Finding CAM References on Colon Cancer ..................................................... 310 Additional Web Resources................................................................................ 320 General References............................................................................................ 335 Vocabulary Builder........................................................................................... 336
APPENDIX C. RESEARCHING NUTRITION ......................................... 339
Overview........................................................................................................... 339
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Contents
Food and Nutrition: General Principles........................................................... 340 Finding Studies on Colon Cancer..................................................................... 344 Federal Resources on Nutrition........................................................................ 347 Additional Web Resources................................................................................ 348 Vocabulary Builder........................................................................................... 354
APPENDIX D. FINDING MEDICAL LIBRARIES.................................... 357
Overview........................................................................................................... 357 Preparation ....................................................................................................... 357 Finding a Local Medical Library ...................................................................... 358 Medical Libraries Open to the Public............................................................... 358
APPENDIX E. YOUR RIGHTS AND INSURANCE ................................. 365
Overview........................................................................................................... 365 Your Rights as a Patient................................................................................... 365 Patient Responsibilities .................................................................................... 369 Choosing an Insurance Plan............................................................................. 370 Medicare and Medicaid .................................................................................... 372 Financial Assistance for Cancer Care............................................................... 375 NORD’s Medication Assistance Programs ..................................................... 378 Additional Resources ........................................................................................ 379
ONLINE GLOSSARIES.................................................... 381 Online Dictionary Directories.......................................................................... 384
COLON CANCER GLOSSARY ...................................... 385 General Dictionaries and Glossaries ................................................................ 408
INDEX................................................................................... 410
Introduction
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INTRODUCTION Overview Dr. C. Everett Koop, former U.S. Surgeon General, once said, “The best prescription is knowledge.”1 The Agency for Healthcare Research and Quality (AHRQ) of the National Institutes of Health (NIH) echoes this view and recommends that every patient incorporate education into the treatment process. According to the AHRQ: Finding out more about your condition is a good place to start. By contacting groups that support your condition, visiting your local library, and searching on the Internet, you can find good information to help guide your treatment decisions. Some information may be hard to find—especially if you don’t know where to look.2 As the AHRQ mentions, finding the right information is not an obvious task. Though many physicians and public officials had thought that the emergence of the Internet would do much to assist patients in obtaining reliable information, in March 2001 the National Institutes of Health issued the following warning: The number of Web sites offering health-related resources grows every day. Many sites provide valuable information, while others may have information that is unreliable or misleading.3
Quotation from http://www.drkoop.com. The Agency for Healthcare Research and Quality (AHRQ): http://www.ahcpr.gov/consumer/diaginfo.htm. 3 Adapted from the NIH, National Cancer Institute (NCI): http://cancertrials.nci.nih.gov/beyond/evaluating.html. 1 2
2
Colon Cancer
Since the late 1990s, physicians have seen a general increase in patient Internet usage rates. Patients frequently enter their doctor’s offices with printed Web pages of home remedies in the guise of latest medical research. This scenario is so common that doctors often spend more time dispelling misleading information than guiding patients through sound therapies. The Official Patient’s Sourcebook on Colon Cancer has been created for patients who have decided to make education and research an integral part of the treatment process. The pages that follow will tell you where and how to look for information covering virtually all topics related to colon cancer, from the essentials to the most advanced areas of research. The title of this book includes the word “official.” This reflects the fact that the sourcebook draws from public, academic, government, and peerreviewed research. Selected readings from various agencies are reproduced to give you some of the latest official information available to date on colon cancer. Given patients’ increasing sophistication in using the Internet, abundant references to reliable Internet-based resources are provided throughout this sourcebook. Where possible, guidance is provided on how to obtain free-ofcharge, primary research results as well as more detailed information via the Internet. E-book and electronic versions of this sourcebook are fully interactive with each of the Internet sites mentioned (clicking on a hyperlink automatically opens your browser to the site indicated). Hard copy users of this sourcebook can type cited Web addresses directly into their browsers to obtain access to the corresponding sites. Since we are working with ICON Health Publications, hard copy Sourcebooks are frequently updated and printed on demand to ensure that the information provided is current. In addition to extensive references accessible via the Internet, every chapter presents a “Vocabulary Builder.” Many health guides offer glossaries of technical or uncommon terms in an appendix. In editing this sourcebook, we have decided to place a smaller glossary within each chapter that covers terms used in that chapter. Given the technical nature of some chapters, you may need to revisit many sections. Building one’s vocabulary of medical terms in such a gradual manner has been shown to improve the learning process. We must emphasize that no sourcebook on colon cancer should affirm that a specific diagnostic procedure or treatment discussed in a research study, patent, or doctoral dissertation is “correct” or your best option. This sourcebook is no exception. Each patient is unique. Deciding on appropriate
Introduction
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options is always up to the patient in consultation with their physician and healthcare providers.
Organization This sourcebook is organized into three parts. Part I explores basic techniques to researching colon cancer (e.g. finding guidelines on diagnosis, treatments, and prognosis), followed by a number of topics, including information on how to get in touch with organizations, associations, or other patient networks dedicated to colon cancer. It also gives you sources of information that can help you find a doctor in your local area specializing in treating colon cancer. Collectively, the material presented in Part I is a complete primer on basic research topics for patients with colon cancer. Part II moves on to advanced research dedicated to colon cancer. Part II is intended for those willing to invest many hours of hard work and study. It is here that we direct you to the latest scientific and applied research on colon cancer. When possible, contact names, links via the Internet, and summaries are provided. It is in Part II where the vocabulary process becomes important as authors publishing advanced research frequently use highly specialized language. In general, every attempt is made to recommend “freeto-use” options. Part III provides appendices of useful background reading for all patients with colon cancer or related disorders. The appendices are dedicated to more pragmatic issues faced by many patients with colon cancer. Accessing materials via medical libraries may be the only option for some readers, so a guide is provided for finding local medical libraries which are open to the public. Part III, therefore, focuses on advice that goes beyond the biological and scientific issues facing patients with colon cancer.
Scope While this sourcebook covers colon cancer, your doctor, research publications, and specialists may refer to your condition using a variety of terms. Therefore, you should understand that colon cancer is often considered a synonym or a condition closely related to the following: ·
Adenocarcinoma of the Colon
·
Bowel Cancer
·
Cancer Colon
4
Colon Cancer
·
Cancer Intestine
·
Cancer of the Colon
·
Cancer of the Large Intestine
·
Carcinoma of the Colon
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Colonic Cancer
·
Colorectal Cancer
·
Intestinal Cancer
In addition to synonyms and related conditions, physicians may refer to colon cancer using certain coding systems. The International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) is the most commonly used system of classification for the world’s illnesses. Your physician may use this coding system as an administrative or tracking tool. The following classification is commonly used for colon cancer:4 ·
153 malignant neoplasm of colon
For the purposes of this sourcebook, we have attempted to be as inclusive as possible, looking for official information for all of the synonyms relevant to colon cancer. You may find it useful to refer to synonyms when accessing databases or interacting with healthcare professionals and medical librarians.
Moving Forward Since the 1980s, the world has seen a proliferation of healthcare guides covering most illnesses. Some are written by patients or their family members. These generally take a layperson’s approach to understanding and coping with an illness or disorder. They can be uplifting, encouraging, and highly supportive. Other guides are authored by physicians or other healthcare providers who have a more clinical outlook. Each of these two styles of guide has its purpose and can be quite useful. As editors, we have chosen a third route. We have chosen to expose you to as many sources of official and peer-reviewed information as practical, for the purpose of educating you about basic and advanced knowledge as 4 This list is based on the official version of the World Health Organization’s 9th Revision, International Classification of Diseases (ICD-9). According to the National Technical Information Service, “ICD-9CM extensions, interpretations, modifications, addenda, or errata other than those approved by the U.S. Public Health Service and the Health Care Financing Administration are not to be considered official and should not be utilized. Continuous maintenance of the ICD-9-CM is the responsibility of the federal government.”
Introduction
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recognized by medical science today. You can think of this sourcebook as your personal Internet age reference librarian. Why “Internet age”? All too often, patients diagnosed with colon cancer will log on to the Internet, type words into a search engine, and receive several Web site listings which are mostly irrelevant or redundant. These patients are left to wonder where the relevant information is, and how to obtain it. Since only the smallest fraction of information dealing with colon cancer is even indexed in search engines, a non-systematic approach often leads to frustration and disappointment. With this sourcebook, we hope to direct you to the information you need that you would not likely find using popular Web directories. Beyond Web listings, in many cases we will reproduce brief summaries or abstracts of available reference materials. These abstracts often contain distilled information on topics of discussion. While we focus on the more scientific aspects of colon cancer, there is, of course, the emotional side to consider. Later in the sourcebook, we provide a chapter dedicated to helping you find peer groups and associations that can provide additional support beyond research produced by medical science. We hope that the choices we have made give you the most options available in moving forward. In this way, we wish you the best in your efforts to incorporate this educational approach into your treatment plan. The Editors
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PART I: THE ESSENTIALS
ABOUT PART I Part I has been edited to give you access to what we feel are “the essentials” on colon cancer. The essentials of a disease typically include the definition or description of the disease, a discussion of who it affects, the signs or symptoms associated with the disease, tests or diagnostic procedures that might be specific to the disease, and treatments for the disease. Your doctor or healthcare provider may have already explained the essentials of colon cancer to you or even given you a pamphlet or brochure describing colon cancer. Now you are searching for more in-depth information. As editors, we have decided, nevertheless, to include a discussion on where to find essential information that can complement what your doctor has already told you. In this section we recommend a process, not a particular Web site or reference book. The process ensures that, as you search the Web, you gain background information in such a way as to maximize your understanding.
Guidelines
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CHAPTER 1. THE ESSENTIALS ON COLON CANCER: GUIDELINES Overview Official agencies, as well as federally funded institutions supported by national grants, frequently publish a variety of guidelines on colon cancer. These are typically called “Fact Sheets” or “Guidelines.” They can take the form of a brochure, information kit, pamphlet, or flyer. Often they are only a few pages in length. The great advantage of guidelines over other sources is that they are often written with the patient in mind. Since new guidelines on colon cancer can appear at any moment and be published by a number of sources, the best approach to finding guidelines is to systematically scan the Internet-based services that post them.
The National Institutes of Health (NIH)5 The National Institutes of Health (NIH) is the first place to search for relatively current patient guidelines and fact sheets on colon cancer. Originally founded in 1887, the NIH is one of the world’s foremost medical research centers and the federal focal point for medical research in the United States. At any given time, the NIH supports some 35,000 research grants at universities, medical schools, and other research and training institutions, both nationally and internationally. The rosters of those who have conducted research or who have received NIH support over the years include the world’s most illustrious scientists and physicians. Among them are 97 scientists who have won the Nobel Prize for achievement in medicine.
5
Adapted from the NIH: http://www.nih.gov/about/NIHoverview.html.
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There is no guarantee that any one Institute will have a guideline on a specific disease, though the National Institutes of Health collectively publish over 600 guidelines for both common and rare diseases. The best way to access NIH guidelines is via the Internet. Although the NIH is organized into many different Institutes and Offices, the following is a list of key Web sites where you are most likely to find NIH clinical guidelines and publications dealing with colon cancer and associated conditions: ·
Office of the Director (OD); guidelines consolidated across agencies available at http://www.nih.gov/health/consumer/conkey.htm
·
National Library of Medicine (NLM); extensive encyclopedia (A.D.A.M., Inc.) with guidelines available at http://www.nlm.nih.gov/medlineplus/healthtopics.html
·
National Cancer Institute (NCI); guidelines available at http://cancernet.nci.nih.gov/pdq/pdq_treatment.shtml
Among the above, the National Cancer Institute (NCI) is particularly noteworthy. The NCI coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.6 Specifically, the Institute: ·
Supports and coordinates research projects conducted by universities, hospitals, research foundations, and businesses throughout this country and abroad through research grants and cooperative agreements.
·
Conducts research in its own laboratories and clinics.
·
Supports education and training in fundamental sciences and clinical disciplines for participation in basic and clinical research programs and treatment programs relating to cancer through career awards, training grants, and fellowships.
·
Supports research projects in cancer control.
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Supports a national network of cancer centers.
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Collaborates with voluntary organizations and other national and foreign institutions engaged in cancer research and training activities.
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Encourages and coordinates cancer research by industrial concerns where such concerns evidence a particular capability for programmatic research.
·
Collects and disseminates information on cancer.
This paragraph has been adapted from the NCI: http://www.nci.nih.gov/. “Adapted” signifies that a passage has been reproduced exactly or slightly edited for this book. 6
Guidelines 11
·
Supports construction of laboratories, clinics, and related facilities necessary for cancer research through the award of construction grants.
The NCI, established under the National Cancer Act of 1937, is the Federal Government’s principal agency for cancer research and training. The National Cancer Act of 1971 broadened the scope and responsibilities of the NCI and created the National Cancer Program. Over the years, legislative amendments have maintained the NCI authorities and responsibilities and added new information dissemination mandates as well as a requirement to assess the incorporation of state-of-the-art cancer treatments into clinical practice. Information dissemination is made possible through the NCI Online at www.cancer.gov. Cancer.gov offers to the public and physicians up-to-date information on the latest cancer research, current and upcoming clinical trials, statistics, research programs, and research funding. The following patient guideline was recently published by the NCI on colon cancer.
What Is Colon Cancer?7 Colon cancer is a disease in which malignant (cancer) cells form in the tissues of the colon. The colon is part of the body’s digestive system. The digestive system removes and processes nutrients (vitamins, minerals, carbohydrates, fats, proteins, and water) from foods and helps pass waste material out of the body. The digestive system is made up of the esophagus, stomach, and the small and large intestines. The first 6 feet of the large intestine are called the large bowel or colon. The last 6 inches are the rectum and the anal canal. The anal canal ends at the anus (the opening of the large intestine to the outside of the body).
Risk Factors Age and health history can affect the risk of developing colon cancer. Risk factors include: ·
Age 50 or older.
The following guidelines appeared on the NCI website on Aug. 26, 2002. The text was last modified in August 2002. The text has been adapted for this sourcebook. 7
12 Colon Cancer
·
A family history of cancer of the colon or rectum.
·
A personal history of cancer of the colon, rectum, ovary, endometrium, or breast.
·
A history of polyps (small noncancerous growths) in the colon.
·
A history of ulcerative colitis (ulcers in the lining of the large intestine).
·
Certain hereditary conditions, such as familial adenomatous polyposis and hereditary nonpolyposis colon cancer (HNPCC; Lynch Syndrome).
Symptoms Possible signs of colon cancer include a change in bowel habits or blood in the stool. These and other symptoms may be caused by colon cancer or by other conditions. A doctor should be consulted if any of the following problems occur: ·
A change in bowel habits.
·
Blood (either bright red or very dark) in the stool.
·
Diarrhea, constipation, or feeling that the bowel does not empty completely.
·
Stools that are narrower than usual.
·
General abdominal discomfort (frequent gas pains, bloating, fullness, or cramps).
·
Weight loss with no known reason.
·
Constant tiredness.
·
Vomiting.
Diagnosis Tests that examine the rectum, rectal tissue, and blood are used to detect (find) and diagnose colon cancer. The following tests and procedures may be used:
Guidelines 13
·
Fecal occult blood test: A small stool sample is placed on a special card and returned to the doctor or lab. This test examines the stool for occult (hidden) blood.
·
Digital rectal examination: The doctor or nurse inserts a lubricated gloved finger into the rectum and feels for lumps or abnormal areas and tests any stool for blood.
·
Barium enema: A procedure in which a liquid containing barium is put into the rectum by way of the anus. Barium is a silver-white metallic compound that helps to show the image of the lower gastrointestinal tract on an x-ray.
·
Sigmoidoscopy: An examination in which a doctor uses a sigmoidoscope (a thin, lighted instrument) to view the inside of the lower colon and rectum for polyps, tumors, or abnormal areas. If the doctor sees a polyp or other abnormal tissue during the procedure, it can be removed and further examined under a microscope.
·
Colonoscopy: An examination of the inside of the entire colon and rectum using a colonoscope (a thin, lighted instrument) inserted into the rectum. If the doctor sees a polyp or other abnormal tissue during the procedure, it can be removed and further examined under a microscope.
·
Biopsy: The removal of cells or tissues for examination under a microscope.
Prognosis Certain factors affect treatment options and prognosis (chance of recovery). The treatment options and prognosis (chance of recovery) depend on the stage of the cancer (whether the cancer is in the inner lining of the colon only, involves the whole colon, or has spread to other places in the body) and the patient’s general health.
Staging After colon cancer has been diagnosed, tests are done to find out if cancer cells have spread within the colon or to other parts of the body. The process used to find out if cancer has spread within the colon or to other parts of the body is called staging. The information gathered from the
14 Colon Cancer
staging process determines the stage of the disease. It is important to know the stage in order to plan the best treatment. The following stages are used for colon cancer: Stage 0 (Carcinoma in Situ) In stage 0, the cancer is found in the innermost lining of the colon only. Stage 0 cancer is also called carcinoma in situ. Stage I In stage I, the cancer has spread beyond the innermost lining of the colon to the second and third layers and involves the inside wall of the colon, but it has not spread to the outer wall of the colon or outside the colon. Stage I colon cancer is sometimes called Dukes’ A colon cancer. Stage II In stage II, cancer has spread outside the colon to nearby tissue, but it has not gone into the lymph nodes. (Lymph nodes are small, bean-shaped structures that are found throughout the body. They filter substances in a fluid called lymph and help fight infection and disease.) Stage II colon cancer is sometimes called Dukes’ B colon cancer. Stage III In stage III, cancer has spread to nearby lymph nodes, but it has not spread to other parts of the body. Stage III colon cancer is sometimes called Dukes’ C colon cancer. Stage IV In stage IV, cancer has spread to other parts of the body, such as the liver or lungs. Stage IV colon cancer is sometimes called Dukes’ D colon cancer.
Guidelines 15
Treatment Options There are different types of treatment for patients with colon cancer. Different types of treatment are available for patients with colon cancer. Some treatments are standard (the currently used treatment), and some are being tested in clinical trials. Before starting treatment, patients may want to think about taking part in a clinical trial. A treatment clinical trial is a research study meant to help improve current treatments or obtain information on new treatments for patients with cancer. When clinical trials show that a new treatment is better than the “standard” treatment, the new treatment may become the standard treatment. Clinical trials are taking place in many parts of the country. Information about ongoing clinical trials is available from the NCI cancer.gov Web site. Choosing the most appropriate cancer treatment is a decision that ideally involves the patient, family, and health care team. Three types of standard treatment are used. These include the following: Surgery Surgery (removing the cancer in an operation) is the most common treatment for all stages of colon cancer. A doctor may remove the cancer using one of the following types of surgery: ·
Local excision: If the cancer is found at a very early stage, the doctor may remove it without cutting through the abdominal wall. Instead, the doctor may put a tube through the rectum into the colon and cut the cancer out. This is called a local excision. If the cancer is found in a polyp (a small bulging piece of tissue), the operation is called a polypectomy.
·
Resection: If the cancer is larger, the doctor will perform a colectomy (removing the cancer and a small amount of healthy tissue around it). The doctor may then perform an anastomosis (sewing the healthy parts of the colon together). The doctor will also usually remove lymph nodes near the colon and examine them under a microscope to see whether they contain cancer.
·
Resection and colostomy: If the doctor is not able to sew the 2 ends of the colon back together, a stoma (an opening) is made on the outside of the body for waste to pass through. This procedure is called a colostomy. Sometimes the colostomy is needed only until the lower colon has healed,
16 Colon Cancer
and then it can be reversed. If the doctor needs to remove the entire lower colon, however, the colostomy may be permanent. Even if the doctor removes all the cancer that can be seen at the time of the operation, some patients may be offered chemotherapy after surgery to kill any cancer cells that are left. Treatment given after the surgery, to increase the chances of a cure, is called adjuvant therapy. Chemotherapy Chemotherapy is the use of drugs to kill cancer cells. Chemotherapy may be taken by mouth, or it may be put into the body by inserting a needle into a vein or muscle. Either type of chemotherapy is called systemic treatment because the drugs enter the bloodstream, travel through the body, and can kill cancer cells throughout the body. Radiation Therapy Radiation therapy is the use of x-rays or other types of radiation to kill cancer cells and shrink tumors. Radiation therapy may use external radiation (using a machine outside the body) or internal radiation. Internal radiation involves putting radioisotopes (materials that produce radiation) through thin plastic tubes into the area where cancer cells are found. Colon cancer may be treated with external radiation. After treatment, a blood test to measure carcinoembryonic antigen (CEA; a substance in the blood that may be increased when colon cancer is present) may be done along with other tests to see if the cancer has come back.
Treatments Being Tested in Clinical Trials Other types of treatment are being tested in clinical trials. These include the following: Biological Therapy Biological therapy is treatment to stimulate the ability of the immune system to fight cancer. Substances made by the body or made in a laboratory are used to boost, direct, or restore the body’s natural defenses against disease.
Guidelines 17
Biological therapy is sometimes called biological response modifier (BRM) therapy or immunotherapy. This summary section refers to specific treatments under study in clinical trials, but it may not mention every new treatment being studied. Information about ongoing clinical trials is available from the NCI cancer.gov Web site.
Treatment Options by Stage Stage 0 Colon Cancer (Carcinoma in Situ) Treatment of stage 0 (carcinoma in situ) may include the following types of surgery: ·
Local excision (surgery to remove the tumor without cutting through the abdominal wall) or simple polypectomy (surgery to remove the cancer from a small bulging piece of tissue).
·
Resection/anastomosis (surgery to remove the cancer and join the cut ends of the colon). This is done when the cancerous tissue is too large to remove by local excision.
Stage I Colon Cancer Treatment of stage I colon cancer is usually the following: ·
Resection/anastomosis (surgery to remove the cancer and join the cut ends of the colon).
Stage II Colon Cancer Treatment of stage II colon cancer may include the following: ·
Resection/anastomosis (surgery to remove the cancer and join the cut ends of the colon).
·
Clinical trials of chemotherapy, radiation therapy, or biological therapy after surgery.
This summary section refers to specific treatments under study in clinical trials, but it may not mention every new treatment being studied.
18 Colon Cancer
Information about ongoing clinical trials is available from the NCI cancer.gov Web site.
Stage III Colon Cancer Treatment of stage III colon cancer may include the following: ·
Resection/anastomosis (surgery to remove the cancer and join the cut ends of the colon), with or without chemotherapy.
·
Clinical trials of chemotherapy, radiation therapy, and/or biological therapy after surgery.
This summary section refers to specific treatments under study in clinical trials, but it may not mention every new treatment being studied. Information about ongoing clinical trials is available from the NCI cancer.gov Web site.
Stage IV Colon Cancer Treatment of stage IV colon cancer may include the following: ·
Resection/anastomosis (surgery to remove the cancer and join the cut ends of the colon or to bypass the tumor).
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Surgery to remove parts of other organs such as the liver, lungs, and ovaries where the cancer may have spread.
·
Chemotherapy.
·
Clinical trials of chemotherapy or biological therapy.
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Radiation therapy may be offered to some patients as palliative therapy (to relieve symptoms).
This summary section refers to specific treatments under study in clinical trials, but it may not mention every new treatment being studied. Information about ongoing clinical trials is available from the NCI cancer.gov Web site.
Guidelines 19
Treatment Options for Recurrent Colon Cancer Treatment of recurrent colon cancer depends on where the cancer has recurred (come back) and the general health of the patient. Treatment for recurrent colon cancer may include the following: ·
Surgery to remove cancer that may have spread to the liver, lungs, or ovaries.
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Surgery to remove cancer cells that have recurred (come back) in the colon.
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Radiation therapy as palliative therapy (to relieve symptoms).
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Chemotherapy as palliative therapy (to relieve symptoms).
· Clinical trials of biological therapy or chemotherapy. This summary section refers to specific treatments under study in clinical trials, but it may not mention every new treatment being studied. Information about ongoing clinical trials is available from the NCI cancer.gov Web site.
To Learn More Call For more information, U.S. residents may call the National Cancer Institute’s (NCI’s) Cancer Information Service toll-free at 1-800-4-CANCER (1-800-4226237) Monday through Friday from 9:00 a.m. to 4:30 p.m. Deaf and hard-ofhearing callers with TTY equipment may call 1-800-332-8615. The call is free and a trained Cancer Information Specialist is available to answer your questions. Web Sites and Organizations The NCI’s Cancer.gov Web site provides online access to information on cancer, clinical trials, and other Web sites and organizations that offer support and resources for cancer patients and their families. There are also many other places where people can get materials and information about cancer treatment and services. Local hospitals may have information on local and regional agencies that offer information about finances, getting to and from treatment, receiving care at home, and dealing with problems associated with cancer treatment.
20 Colon Cancer
Publications The NCI has booklets and other materials for patients, health professionals, and the public. These publications discuss types of cancer, methods of cancer treatment, coping with cancer, and clinical trials. Some publications provide information on tests for cancer, cancer causes and prevention, cancer statistics, and NCI research activities. NCI materials on these and other topics may be ordered online or printed directly from the NCI Publications Locator. These materials can also be ordered by telephone from the Cancer Information Service toll free at 1-800-4-CANCER (1-800-422-6237), TTY at 1800-332-8615.
LiveHelp The NCI’s LiveHelp service, a program available on several of the Institute’s Web sites, provides Internet users with the ability to chat online with an Information Specialist. The service is available from 9:00 a.m. to 10:00 p.m. Eastern time, Monday through Friday. Information Specialists can help Internet users find information on NCI Web sites and answer questions about cancer. Write For more information from the NCI, please write to this address: National Cancer Institute Office of Communications 31 Center Drive, MSC 2580 Bethesda, MD 20892-2580
About PDQ PDQ Is a Comprehensive Cancer Database Available on Cancer.gov PDQ is the National Cancer Institute’s (NCI’s) comprehensive cancer information database. Most of the information contained in PDQ is available online at Cancer.gov (http://cancer.gov), the NCI’s Web site. PDQ is provided as a service of the NCI. The NCI is part of the National Institutes of Health, the federal government’s focal point for biomedical research.
Guidelines 21
PDQ Contains Cancer Information Summaries The PDQ database contains summaries of the latest published information on cancer prevention, detection, genetics, treatment, supportive care, and complementary and alternative medicine. Most summaries are available in two versions. The health professional versions provide detailed information written in technical language. The patient versions are written in easy-tounderstand, non-technical language. Both versions provide current and accurate cancer information. The PDQ cancer information summaries are developed by cancer experts and reviewed regularly. Editorial Boards made up of experts in oncology and related specialties are responsible for writing and maintaining the cancer information summaries. The summaries are reviewed regularly and changes are made as new information becomes available. The date on each summary (“Date Last Modified”) indicates the time of the most recent change.
PDQ Contains Information on Clinical Trials Before starting treatment, patients may want to think about taking part in a clinical trial. A clinical trial is a study to answer a scientific question, such as whether one treatment is better than another. Trials are based on past studies and what has been learned in the laboratory. Each trial answers certain scientific questions in order to find new and better ways to help cancer patients. During treatment clinical trials, information is collected about new treatments, the risks involved, and how well they do or do not work. If a clinical trial shows that a new treatment is better than one currently being used, the new treatment may become “standard.” Listings of clinical trials are included in PDQ and are available online at Cancer.gov (http://cancer.gov/clinical_trials). Descriptions of the trials are available in health professional and patient versions. Many cancer doctors who take part in clinical trials are also listed in PDQ. For more information, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237); TTY at 1-800-332-8615.
More Guideline Sources The guideline above on colon cancer is only one example of the kind of material that you can find online and free of charge. The remainder of this chapter will direct you to other sources which either publish or can help you
22 Colon Cancer
find additional guidelines on topics related to colon cancer. Many of the guidelines listed below address topics that may be of particular relevance to your specific situation or of special interest to only some patients with colon cancer. Due to space limitations these sources are listed in a concise manner. Do not hesitate to consult the following sources by either using the Internet hyperlink provided, or, in cases where the contact information is provided, contacting the publisher or author directly. Topic Pages: MEDLINEplus For patients wishing to go beyond guidelines published by specific Institutes of the NIH, the National Library of Medicine has created a vast and patientoriented healthcare information portal called MEDLINEplus. Within this Internet-based system are “health topic pages.” You can think of a health topic page as a guide to patient guides. To access this system, log on to http://www.nlm.nih.gov/medlineplus/healthtopics.html. From there you can either search using the alphabetical index or browse by broad topic areas. If you do not find topics of interest when browsing health topic pages, then you can choose to use the advanced search utility of MEDLINEplus at http://www.nlm.nih.gov/medlineplus/advancedsearch.html. This utility is similar to the NIH Search Utility, with the exception that it only includes material linked within the MEDLINEplus system (mostly patient-oriented information). It also has the disadvantage of generating unstructured results. We recommend, therefore, that you use this method only if you have a very targeted search. The Combined Health Information Database (CHID) CHID Online is a reference tool that maintains a database directory of thousands of journal articles and patient education guidelines on colon cancer and related conditions. One of the advantages of CHID over other sources is that it offers summaries that describe the guidelines available, including contact information and pricing. CHID’s general Web site is http://chid.nih.gov/. To search this database, go to http://chid.nih.gov/detail/detail.html. In particular, you can use the advanced search options to look up pamphlets, reports, brochures, and information kits. The following was recently posted in this archive:
Guidelines 23
·
Colon Book: A Look at Polyps and Colon Cancer, Their Treatment, and Your Prospects for Recovery. Source: San Bruno, CA: StayWell Company. 1999. 15 p. Contact: Available from Staywell Company. Order Department, 1100 Grundy Lane, San Bruno, CA 94066-9821. (800) 333-3032. Fax (650) 2444512. Price: $1.25 per copy; plus shipping and handling. Summary: This patient education brochure describes colon polyps and colon cancer, their treatment, and prognosis. Written in nontechnical language, the brochure notes that it can be quite unsettling when a doctor suspects that the patient has a growth in their colon. However, most colon growths can be removed swiftly. And even if the growth is cancerous, with early medical treatment, prognosis is good. A prompt evaluation is the key to diagnosing a colon growth. A medical history, thorough exam, and diagnostic tests (including digital rectal exam, sigmoidoscopy, barium enema, and colonoscopy) help the doctor diagnose the colon problem and plan the right treatment. Surgical treatment may involve removal of the colon growth or growths; if cancer is found, further treatment (such as chemotherapy or radiation) may be needed. After recovery from surgery and any other treatments, the patient can slowly return to their daily activities. Followup exams, a healthy diet, and help from friends, family, and support groups can help the patient get back to his or her routine as quickly as possible. One section of the brochure illustrates and describes the healthy colon, how it functions, and how unhealthy growths (polyps and cancer) can occur. The brochure then describes preoperative care, the different types of colon resections that may be utilized (right hemicolectomy, transverse colectomy, left colectomy, and sigmoid colectomy), what to expect during the hospital stay, and postoperative recovery at home. The brochure is illustrated with full color line drawings and is available in English or Spanish. 12 figures.
·
Understanding Colon Cancer Screening Source: Manchester, MA: American Society for Gastrointestinal Endoscopy. 2001. [2 p.]. Contact: Available from American Society for Gastrointestinal Endoscopy. 13 Elm Street, Manchester, MA 01944. (508) 526-8330. Price: Single copy free. Summary: This brochure educates readers about colon cancer screening. The brochure offers six True or False statements about colorectal cancer (CRC) screening, then explains the correct answer for each. Topics include the incidence of CRC in men versus women; the indications for
24 Colon Cancer
testing; the time involved in a colonoscopy screening examination; the mortality associated with CRC; diagnostic tests used to screen for colon cancer; and prevention of CRC. Colorectal cancer affects an equal number of men and women. Beginning at age 50, all men and women should be screened for colorectal cancer, even if they are experiencing no problems or symptoms. Colonoscopy is almost always done on an outpatient basis; the test is safe and the procedure itself typically takes less than 30 minutes. Colorectal cancer is the third leading cause of cancer deaths in women in the United States. Tests used for screening for CRC include digital rectal exam, stool blood test, barium enema, flexible sigmoidoscopy, and colonoscopy. The brochure emphasizes that colon cancer is often preventable, so screening is very important. ·
ACG Recommendations on Colorectal Cancer Screening for Average and Higher Risk Patients in Clinical Practice Source: Arlington, VA: American College of Gastroenterology. 200x. 25 p. Contact: Available from American College of Gastroenterology. 4900 B South 31st Street, Arlington, VA 22206-1656. (703) 820-7400. Fax (703) 9314520. Price: Single copy free. Summary: This booklet outlines the preferred colorectal cancer screening recommendations of the American College of Gastroenterology (ACG) and presents an update of the ACG position on screening as outlined by the Agency for Healthcare Policy and Research (AHCPR). The AHCPR's recommendations presented a menu of options for screening average risk persons. These options have similar cost-effectiveness ratios, however, there are substantial differences between the various options regarding their effectiveness, initial costs, and to a lesser degree, risk. The ACG continues to endorse the AHCPR guideline. The update recommendation as presented in the booklet is meant to reflect trends in the rapidly changing perceptions of colorectal cancer prevention strategies among clinical gastroenterologists in both academic and private practice. The preferred screening strategy for persons over age 50 at average risk for colorectal cancer is colonoscopy every 10 years. An alternative strategy for this population (used when resources, expertise, or reimbursement for screening colonoscopy are not available) is flexible sigmoidoscopy every 5 years plus annual fecal occult blood testing. The booklet outlines other screening strategies include barium enema, and CT (computed tomography) and magnetic resonance (MR) colonography (also called virtual colonoscopy). The booklet then discusses screening for people in high risk categories, including those with a personal or family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, and strong family history of colon cancer. The booklet includes
Guidelines 25
extensive tables that summarize the information and guidelines presented in the text. 2 figures. 4 tables. 142 references. ·
Now Medicare Covers a Test That Could Save Your Life: What You Should Know About New Medicare Colorectal Cancer Screening Benefit [and] Screening for Your Family Source: Arlington, VA: American College of Gastroenterology. 1998. 6 p. Contact: Available from American College of Gastroenterology. 4900 B South 31st Street, Arlington, VA 22206. (800) 478-2876. Price: Single copy free. Summary: This brochure describes colorectal cancer screening and new Medicare reimbursement (payment) for its costs. Screening can prevent cancer by removing pre-cancerous growths (polyps), and early detection allows diagnosis before cancers have a chance to spread. Up to 80 percent of colon cancer deaths can be prevented by timely removal of precancerous polyps. Congress passed a new law which directed Medicare to pay for three tests for colorectal cancer screening. Fecal occult blood tests will be paid for annually; flexible sigmoidoscopy will be paid for once every four years for average risk patients; and screening colonoscopy will be paid for once every two years for high risk patients. The brochure describes each of these tests, as well as barium X-ray, noting the advantages and disadvantages of each. High risk patients are those who have a personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease (Crohn's disease or ulcerative colitis; those who have a close relative who has had colorectal cancer or an adenomatous polyp; and those who have a family history of familial adenomatous polyposis or of hereditary non-polyposis colorectal cancer. The brochure concludes with information about choosing a physician to do these screening tests. A physician's insert is provided with the brochure; the insert lists the HCPCS Codes and Guidelines for Reimbursement for colorectal cancer screening tests. (AA-M).
·
Colorectal Cancer Screening: Early Detection Source: San Ramon, CA: Health Information Network, Inc. 1996. 14 p. Contact: Available from HIN, Inc. 231 Market Place, Number 331, San Ramon, CA 94583. (800) HIN-1121. Fax (925) 358-4377. Website: www.hinbooks.com. Price: $1.95 suggested list price; professional and bulk discounts available. Order number 206. ISBN: 1885274629. Summary: This brochure provides readers with basic information about screening for colorectal cancer. The brochure defines a screening test as a type of medical examination that may find cancer early, before it causes
26 Colon Cancer
symptoms or pain. Colorectal cancer is cancer in any part of the large intestine, which includes the colon and rectum. Colorectal cancer is one of the most curable types of cancer, with a success rate of over 90 percent when found in its early stages. Written in language that is easy to read, the brochure covers the anatomy of the colon and rectum, the nature of cancer, risk factors for colorectal cancer, screening tests for colorectal cancer (fecal occult blood test, flexible sigmoidoscopy, colonoscopy, barium enema with air contrast examination, and digital rectal examination), symptoms of colorectal cancer, and patient followup. The brochure provides the addresses and phone numbers of the American Cancer Society and the National Cancer Institute. A brief glossary of terms is also included. ·
Colorectal Cancer: Questions and Answers Source: Arlington Heights, IL: American Society of Colon and Rectal Surgeons. 1996. [2 p.]. Contact: Available from American Society for Colon and Rectal Surgeons (ASCRS). 85 West Algonquin Road, Suite 550, Arlington Heights, IL 60005. (800) 791-0001 or (847) 290-9184. Website: www.fascrs.org. Price: Single copy free. Summary: This brochure describes colorectal cancer, the second most common cancer in the United States, striking 140,000 people annually and causing 60,000 deaths. The author stresses that the disease is potentially curable if diagnosed in the early stages. Risk factors include age, family history of colorectal cancer and polyps, and personal history of ulcerative colitis, colon polyps, or cancer of other organs, especially of the breast or uterus. Nearly all colon and rectal cancer begins in benign polyps; these premalignant growths occur on the bowel wall and may eventually increase in size and become cancer. The most common symptoms are rectal bleeding and changes in bowel habits, such as constipation or diarrhea. Unfortunately, many polyps and early cancers fail to produce symptoms. Therefore, routine physicals should include colorectal cancer detection procedures after age 40, including digital rectal exams, a chemical test of stool for blood, and sigmoidoscopy (the inspection of the lower bowel with a lighted tubular instrument). Colorectal cancer requires surgery in nearly all cases for a complete cure. Radiation and chemotherapy are sometimes used in addition to surgery. The brochure also outlines steps that can reduce the risk of contracting colon cancer. One way is having benign polyps removed by an outpatient procedure called colonoscopy. There is also some evidence that diet (high fiber, low fat) may play a significant role in preventing colorectal cancer. Readers are also encouraged to pay attention to changes in their bowel
Guidelines 27
habits. The brochure concludes with a brief description of the specialty of colon and rectal surgeons. 1 figure. ·
Follow Up Evaluation After Surgery for Colorectal Cancer: Questions and Answers Source: Arlington Heights, IL: American Society of Colon and Rectal Surgeons. 1992. 4 p. Contact: Available from American Society of Colon and Rectal Surgeons. 85 West Algonquin Road, Suite 550, Arlington Heights, IL 60005. (800) 791-0001 or (847) 290-9184. Fax (847) 290-9203. Price: Single copy free; bulk copies available. Summary: This patient education brochure provides information about patient follow-up evaluations after surgery for colorectal cancer. Written in a question and answer format, the brief brochure discusses the reasons why follow-up evaluations are crucial, the recommended length of a followup program, what to expect at a followup visit, and the importance of screening close family members who are at increased risk for colon and rectal cancer.
The National Guideline Clearinghouse™ The National Guideline Clearinghouse™ offers hundreds of evidence-based clinical practice guidelines published in the United States and other countries. You can search their site located at http://www.guideline.gov by using the keyword “colon cancer” or synonyms. The following was recently posted: ·
ACR Appropriateness Criteria™ for pre-treatment staging of colorectal cancer. Source: American College of Radiology.; 1996 (revised 1999); 8 pages http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=00 1626&sSearch_string=colon+cancer
·
ACR Appropriateness Criteria™ for screening for colorectal cancer. Source: American College of Radiology.; 1998; 7 pages http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=00 1639&sSearch_string=colon+cancer
28 Colon Cancer
·
Adjuvant therapy for stage II colon cancer following complete resection. Source: Cancer Care Ontario Practice Guidelines Initiative.; 1997 August 25 (updated online 2000 Apr) http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=00 2235&sSearch_string=colon+cancer
·
Adjuvant therapy for stage III colon cancer following complete resection. Source: Cancer Care Ontario Practice Guidelines Initiative.; 1997 August 25 (updated online 2000 Apr); Various pagings http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=00 2242&sSearch_string=colon+cancer
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American Gastroenterological Association medical position statement: hereditary colorectal cancer and genetic testing. Source: American Gastroenterological Association.; 2001 April 18; 3 pages http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=00 2283&sSearch_string=colon+cancer
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American Gastroenterological Association medical position statement: impact of dietary fiber on colon cancer occurrence. Source: American Gastroenterological Association.; 1999 November 15 (reviewed 2001); 2 pages http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=00 2296&sSearch_string=colon+cancer
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Colorectal cancer screening. Source: Institute for Clinical Systems Improvement.; 1995 May (revised 2001 Jul) http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=00 2251&sSearch_string=colon+cancer
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·
Colorectal cancer screening: clinical guidelines and rationale. Source: American Gastroenterological Association.; 1997 February (reviewed 2001); 48 pages http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=00 0045&sSearch_string=colon+cancer
·
Preventive health care, 2001 update: colorectal cancer screening. Source: Canadian Task Force on Preventive Health Care.; 2001; 2 pages http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=00 2120&sSearch_string=colon+cancer
·
Recommended colorectal cancer surveillance guidelines by the American Society of Clinical Oncology. Source: American Society of Clinical Oncology.; 1999 April (revised 2000 Oct); 10 pages http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=00 1111&sSearch_string=colon+cancer
Healthfinder™ Healthfinder™ is an additional source sponsored by the U.S. Department of Health and Human Services which offers links to hundreds of other sites that contain healthcare information. This Web site is located at http://www.healthfinder.gov. Again, keyword searches can be used to find guidelines. The following was recently found in this database: ·
Frequently Asked Questions For Caregivers Summary: A series of commonly asked questions and answers provided for persons caring for patients with colon (colorectal) cancer. Source: Colon Cancer Alliance http://www.healthfinder.gov/scripts/recordpass.asp?RecordType=0&R ecordID=6073
The NIH Search Utility After browsing the references listed at the beginning of this chapter, you may want to explore the NIH Search Utility. This allows you to search for
30 Colon Cancer
documents on over 100 selected Web sites that comprise the NIH-WEBSPACE. Each of these servers is “crawled” and indexed on an ongoing basis. Your search will produce a list of various documents, all of which will relate in some way to colon cancer. The drawbacks of this approach are that the information is not organized by theme and that the references are often a mix of information for professionals and patients. Nevertheless, a large number of the listed Web sites provide useful background information. We can only recommend this route, therefore, for relatively rare or specific disorders, or when using highly targeted searches. To use the NIH search utility, visit the following Web page: http://search.nih.gov/index.html.
Additional Web Sources A number of Web sites that often link to government sites are available to the public. These can also point you in the direction of essential information. The following is a representative sample: ·
AOL: http://search.aol.com/cat.adp?id=168&layer=&from=subcats
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drkoop.comÒ: http://www.drkoop.com/conditions/ency/index.html
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Family Village: http://www.familyvillage.wisc.edu/specific.htm
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Google: http://directory.google.com/Top/Health/Conditions_and_Diseases/
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Med Help International: http://www.medhelp.org/HealthTopics/A.html
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Open Directory Project: http://dmoz.org/Health/Conditions_and_Diseases/
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Yahoo.com: http://dir.yahoo.com/Health/Diseases_and_Conditions/
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WebMDÒHealth: http://my.webmd.com/health_topics
Vocabulary Builder The material in this chapter may have contained a number of unfamiliar words. The following Vocabulary Builder introduces you to terms used in this chapter that have not been covered in the previous chapter: Abdominal: Having to do with the abdomen, which is the part of the body between the chest and the hips that contains the pancreas, stomach, intestines, liver, gallbladder, and other organs. [NIH] Adjuvant: A substance which aids another, such as an auxiliary remedy; in
Guidelines 31
immunology, nonspecific stimulator (e.g., BCG vaccine) of the immune response. [EU] Anal: Having to do with the anus, which is the posterior opening of the large bowel. [NIH] Anastomosis: A procedure to connect healthy sections of tubular structures in the body after the diseased portion has been surgically removed. [NIH] Anus: The opening of the rectum to the outside of the body. [NIH] Barium: An element of the alkaline earth group of metals. It has an atomic symbol Ba, atomic number 56, and atomic weight 138. All of its acid-soluble salts are poisonous. [NIH] Benign: Not cancerous; does not invade nearby tissue or spread to other parts of the body. [NIH] Biopsy: The removal of cells or tissues for examination under a microscope. When only a sample of tissue is removed, the procedure is called an incisional biopsy or core biopsy. When an entire tumor or lesion is removed, the procedure is called an excisional biopsy. When a sample of tissue or fluid is removed with a needle, the procedure is called a needle biopsy or fineneedle aspiration. [NIH] Bowel: The long tube-shaped organ in the abdomen that completes the process of digestion. There is both a small and a large bowel. Also called the intestine. [NIH] Bypass: A surgical procedure in which the doctor creates a new pathway for the flow of body fluids. [NIH] Carbohydrate: An aldehyde or ketone derivative of a polyhydric alcohol, particularly of the pentahydric and hexahydric alcohols. They are so named because the hydrogen and oxygen are usually in the proportion to form water, (CH2O)n. The most important carbohydrates are the starches, sugars, celluloses, and gums. They are classified into mono-, di-, tri-, poly- and heterosaccharides. [EU] Carcinoma: Cancer that begins in the skin or in tissues that line or cover internal organs. [NIH] CEA: Carcinoembryonic antigen. A substance that is sometimes found in an increased amount in the blood of people with certain cancers. [NIH] Cell: The individual unit that makes up all of the tissues of the body. All living things are made up of one or more cells. [NIH] Chemotherapy: Treatment with anticancer drugs. [NIH] Colectomy: An operation to remove the colon. An open colectomy is the removal of the colon through a surgical incision made in the wall of the abdomen. Laparoscopic-assisted colectomy uses a thin, lighted tube attached
32 Colon Cancer
to a video camera. It allows the surgeon to remove the colon without a large incision. [NIH] Colitis: Inflammation of the colon. [NIH] Colon: The long, coiled, tubelike organ that removes water from digested food. The remaining material, solid waste called stool, moves through the colon to the rectum and leaves the body through the anus. [NIH] Colonoscope: A thin, lighted tube used to examine the inside of the colon. [NIH]
Colonoscopy: An examination of the inside of the colon using a thin, lighted tube (called a colonoscope) inserted into the rectum. If abnormal areas are seen, tissue can be removed and examined under a microscope to determine whether disease is present. [NIH] Colorectal: Having to do with the colon or the rectum. [NIH] Colostomy: An opening into the colon from the outside of the body. A colostomy provides a new path for waste material to leave the body after part of the colon has been removed. [NIH] Constipation: Infrequent or difficult evacuation of the faeces. [EU] Diarrhea: Passage of excessively liquid or excessively frequent stools. [NIH] Endometrium: The layer of tissue that lines the uterus. [NIH] Endoscopy: The use of a thin, lighted tube (called an endoscope) to examine the inside of the body. [NIH] Enema: The injection of a liquid through the anus into the large bowel. [NIH] Esophagus: The muscular tube through which food passes from the throat to the stomach. [NIH] Gastroenterologist: A doctor who specializes in diagnosing and treating disorders of the digestive system. [NIH] Gastrointestinal: Refers to the stomach and intestines. [NIH] Immunotherapy: Treatment to stimulate or restore the ability of the immune system to fight infection and disease. Also used to lessen side effects that may be caused by some cancer treatments. Also called biological therapy or biological response modifier (BRM) therapy. [NIH] Intestine: A long, tube-shaped organ in the abdomen that completes the process of digestion. There is both a large intestine and a small intestine. Also called the bowel. [NIH] Liver: A large, glandular organ located in the upper abdomen. The liver cleanses the blood and aids in digestion by secreting bile. [NIH] Lymph: The almost colorless fluid that travels through the lymphatic system and carries cells that help fight infection and disease. [NIH]
Guidelines 33
Malignant: Cancerous; a growth with a tendency to invade and destroy nearby tissue and spread to other parts of the body. [NIH] Occult: Obscure; concealed from observation, difficult to understand. [EU] Oncology: The study of cancer. [NIH] Ovaries: The pair of female reproductive glands in which the ova, or eggs, are formed. The ovaries are located in the pelvis, one on each side of the uterus. [NIH] Ovary: Either of the paired glands in the female that produce the female germ cells and secrete some of the female sex hormones. [NIH] Palliative: 1. affording relief, but not cure. 2. an alleviating medicine. [EU] Polyp: A growth that protrudes from a mucous membrane. [NIH] Polyposis: The development of numerous polyps (growths that protrude from a mucous membrane). [NIH] Postoperative: After surgery. [NIH] Precancerous: A term used to describe a condition that may (or is likely to) become cancer. Also called premalignant. [NIH] Premalignant: A term used to describe a condition that may (or is likely to) become cancer. Also called precancerous. [NIH] Preoperative: Preceding an operation. [EU] Proteins: Polymers of amino acids linked by peptide bonds. The specific sequence of amino acids determines the shape and function of the protein. [NIH]
Radioisotope: An unstable element that releases radiation as it breaks down. Radioisotopes can be used in imaging tests or as a treatment for cancer. [NIH] Radiology: The use of radiation (such as x-rays) or other imaging technologies (such as ultrasound and magnetic resonance imaging) to diagnose or treat disease. [NIH] Rectal: By or having to do with the rectum. The rectum is the last 8 to 10 inches of the large intestine and ends at the anus. [NIH] Rectum: The last 8 to 10 inches of the large intestine. [NIH] Resection: Removal of tissue or part or all of an organ by surgery. [NIH] Screening: Checking for disease when there are no symptoms. [NIH] Sigmoidoscope: A thin, lighted tube used to view the inside of the colon. [NIH]
Sigmoidoscopy: Inspection of the lower colon using a thin, lighted tube called a sigmoidoscope. Samples of tissue or cells may be collected for examination under a microscope. Also called proctosigmoidoscopy. [NIH]
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Staging: Performing exams and tests to learn the extent of the cancer within the body, especially whether the disease has spread from the original site to other parts of the body. [NIH] Stomach: An organ that is part of the digestive system. It helps in the digestion of food by mixing it with digestive juices and churning it into a thin liquid. [NIH] Stool: The waste matter discharged in a bowel movement; feces. [NIH] Systemic: Affecting the entire body. [NIH] Tomography: A series of detailed pictures of areas inside the body; the pictures are created by a computer linked to an x-ray machine. [NIH] Uterus: The small, hollow, pear-shaped organ in a woman's pelvis. This is the organ in which a fetus develops. Also called the womb. [NIH]
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CHAPTER 2. SEEKING GUIDANCE Overview Some patients are comforted by the knowledge that a number of organizations dedicate their resources to helping people with colon cancer. These associations can become invaluable sources of information and advice. Many associations offer aftercare support, financial assistance, and other important services. Furthermore, healthcare research has shown that support groups often help people to better cope with their conditions.8 In addition to support groups, your physician can be a valuable source of guidance and support. Therefore, finding a physician that can work with your unique situation is a very important aspect of your care. In this chapter, we direct you to resources that can help you find patient organizations and medical specialists. We begin by describing how to find associations and peer groups that can help you better understand and cope with colon cancer. The chapter ends with a discussion on how to find a doctor that is right for you.
Associations and Colon Cancer As mentioned by the Agency for Healthcare Research and Quality, sometimes the emotional side of an illness can be as taxing as the physical side.9 You may have fears or feel overwhelmed by your situation. Everyone has different ways of dealing with disease or physical injury. Your attitude, your expectations, and how well you cope with your condition can all Churches, synagogues, and other houses of worship might also have groups that can offer you the social support you need. 9 This section has been adapted from http://www.ahcpr.gov/consumer/diaginf5.htm. 8
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influence your well-being. This is true for both minor conditions and serious illnesses. For example, a study on female breast cancer survivors revealed that women who participated in support groups lived longer and experienced better quality of life when compared with women who did not participate. In the support group, women learned coping skills and had the opportunity to share their feelings with other women in the same situation. In addition to associations or groups that your doctor might recommend, we suggest that you consider the following list (if there is a fee for an association, you may want to check with your insurance provider to find out if the cost will be covered): ·
American College of Surgeons Address: American College of Surgeons 633 North Saint Clair Street, Chicago, IL 60611-3211 Telephone: (312) 202-5000 Toll-free: (888) 939-3333 Fax: (312) 202-5001 Email: None. Web Site: http://www.facs.org/ Background: The American College of Surgeons (ACS) is a scientific and educational association of surgeons that was founded in 1913 to improve the quality of care for the surgical patient by setting high standards for surgical education and practice. The College currently has more than 56,000 Fellows including more than 3,400 Fellows in other countries, making it the largest organization of surgeons in the world. There are presently more than 3,300 Associate Fellows. The American College of Surgeons sponsors a variety of continuing medical education (CME) programs and conducts various programs through its Commission on Cancer to improve the care of the cancer patient. Through its Committee on Trauma, ACS works to improve the care of injured and critically ill patients before, en route to, and during hospitalization. The College also monitors and analyzes socioeconomic, legislative, and regulatory issues affecting the field of surgery through its Socioeconomic Affairs Department and Washington, DC office and serves as a sponsoring organization for the Residency Review Committees for Colon and Rectal Surgery, Neurological Surgery, Otolaryngology, Plastic Surgery, Surgery, Thoracic Surgery, and Urology and supports postdoctoral education in surgery through several scholarship programs. Through its Office of Public Information, ACS provides public education services to patients with general information to help them make informed decisions about surgical care, and distributes a brochure series on frequently performed surgical procedures.
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American Society of Colon and Rectal Surgeons Address: American Society of Colon and Rectal Surgeons 85 West Algonquin Road, Suite 550, Arlington Heights, IL 60005 Telephone: (847) 290-9184 Toll-free: (888) 939-3333 Fax: (847) 290-9203 Email:
[email protected] Web Site: http://www.fascrs.org/ Background: The American Society of Colon and Rectal Surgeons (ASCRS) is a medical professional society representing more than 1,000 board certified colon and rectal surgeons and other surgeons. The Society's membership is dedicated to advancing and promoting the science and practice of the treatment of individuals with diseases and disorders affecting the colon, rectum, and anus. The Society's Standards Task Force is committed to developing practice parameters for the treatment of colon and rectal diseases and disorders including ambulatory anorectal surgery, treatment of hemorrhoids, management of anal fissure, treatment of rectal carcinoma, and detection of colorectal neoplasms. The Society's web site provides links to such practice parameters as well as to core subject updates on such topics as colonic volvulus, ostomies and stomal therapy, familial adenomatous polyposis, and colon and rectal cancer. The Society also publishes the 'Washington Report,' which offers updates on current federal legislative and regulatory actions, and provides professional publications including the 'ASCRS Newsletter' and the Society's official journal entitled 'Diseases of the Colon and Rectum.' The ASCRS also provides an email discussion group (listserv) for the benefit of ASCRS members and fellows in colon and rectal surgery. The primary purpose of the listserv is to provide a forum for the informal discussion of clinical cases and other issues of general interest to the colon and rectal surgeon community. The Society's web site also provides information on the Collaborative Group of the Americas on Inherited Colorectal Cancer. The Group was established in 1995 to improve understanding of the basic science of inherited colorectal cancer and the clinical management of affected families. Its broad aims are to promote education of physicians, allied health care professionals, patients, and their families; provide linkage to clinical and chemoprevention trials; promote the integration of molecular and clinical research at local and national levels; and serve as a resource for developing similar genetic registers. The American Society of Colon and Rectal Surgeons also provides patient information on a variety of topics including anal abscess/fistula, anal fissure, anal warts, bowel incontinence, colonoscopy, colorectal cancer, constipation, Crohn's
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disease, diverticular disease, irritable bowel syndrome, ostomy, rectal prolapse, and ulcerative colitis. ·
Canadian Cancer Society Address: Canadian Cancer Society 10 Alcorn Avenue, Suite 200, Toronto, Ontario, M4V 3B1, Canada Telephone: (416) 961-7223 Toll-free: (888) 939-3333 Fax: (416) 961-4189 Email:
[email protected] Web Site: http://www.cancer.ca/ Background: The Canadian Cancer Society (CCS) is a national, nonprofit, community-based organization that is dedicated to eradicating cancer and improving the quality of life of people living with cancer. Established in 1937, the Society currently has 350,000 volunteers, over 600 community locations, 10 provincial divisions, and one national office. The Canadian Cancer Society works to achieve its mission by promoting and supporting cancer research, educating the public, engaging in public policy advocacy efforts, and providing patient and family services. The Society is committed to funding medical research, awarding fellowships to support advanced clinical training in oncology, and funding behavioral research to help determine the best ways to promote lifestyle changes that may reduce the risk of cancer. The Society's public education programs work to promote the prevention and early detection of cancer by providing information and skill development through programs, advocacy, and collaboration. In addition, the Canadian Cancer Society works with coalitions of health, medical, research, and professional organizations to lobby Parliament and provincial legislatures concerning public policies that will promote health and prevent disease. The Society's patient services program is committed to meeting the social, emotional, informational, and spiritual needs of people with cancer and their families. Program services include the Society's Cancer Information Service, which provides affected individuals and family members with current information about all aspects of cancer; networking programs that enable individuals with cancer to communicate with trained volunteers who have also been affected by cancer; transportation to treatment centers and other practical assistance; and educational publications for affected individuals and family members.
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CancerOnline Address: Telephone: (410) 955-3875 Toll-free: (888) 939-3333 Email:
[email protected] Web Site: http://www.canceronline.org Background: CancerOnline is a nonprofit site on the Internet dedicated to providing individuals with cancer easy access to clinical information and offering extensive practical support and encouragement. CancerOnline collaborates with many different cancer care centers and organizations and provides original material contributed by cancer patients, caregivers, and cancer care specialists in private practice and a variety of cancer centers. CancerOnline's content is overseen by three advisory panels made up of oncologists, radiologists, and clinical care providers who want to help cancer patients become students of their disease; other cancer care specialists and providers of psychosocial support who want to encourage patients to participate actively in their treatment; and patients, survivors, and caregivers who want to help patients live with vitality and hope even in the face of a life-challenging illness. CancerOnline offers several major areas within its site including 'About CancerOnline,' 'Support and Encouragement,' 'Getting Information,' 'Participating in This Community,' and 'Special Features.' The site offers several sources of clinical information that can be accessed through a network of subject areas; practical advice before, during, and after treatment; stories from individuals who have triumphed over cancer; opportunities for affected individuals and families to contribute personal stories, creative expressions, commentaries, and questions; hints on how to obtain additional information on and off the Internet; dynamic linkage to additional web sites that provide information and support to those with particular types of cancer; and more. CancerOnline provides information and support to individuals with any type of cancer including Bladder Cancer, Breast Cancer, Colon and Rectal Cancer, Liver Cancer, Lymphoma, Ovarian Cancer, Prostate Cancer, Stomach Cancer, Uterine Cancer, Pediatric Cancers, Brain Tumors, Head and Neck Cancer, Leukemia, Lung Cancer, Melanoma, Pancreatic Cancer, Skin Cancer, Thyroid Cancer, and Rare Adult Cancers.
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David G. Jagelman Inherited Colorectal Cancer Registries Address: David G. Jagelman Inherited Colorectal Cancer Registries Cleveland Clinic Foundation, T10-Medical Genetics, 9500 Euclid Avenue, Cleveland, OH 44195 Telephone: (216) 444-6470 Toll-free: (800) 998-4785
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Fax: (216) 445-6935 Email:
[email protected] Background: Established in 1978, the David G. Jagelman Inherited Colorectal Cancer Registries is a not-for-profit academic medical center recognized as a National Referral Center and an international resource for diseases of the colon and rectum. Dedicated to identifying, educating, and serving affected individuals, the organization has an educational division, a research institute, and a hospital and outpatient clinic. The organization offers risk assessments and appropriate screening tests; maintains computerized registries of affected individuals and those who may be at risk (e.g., for Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer, and Familial Colon Cancer). It suggests surveillance protocols and reviews surgical options for affected individuals. David G. Jagelman Inherited Colorectal Cancer Registries also provides a variety of educational and support materials including brochures, pamphlets, articles, and a newsletter called 'Family Matters.'. ·
Gastrointestinal Polyposis and Hereditary Colon Cancer Registry Address: Gastrointestinal Polyposis and Hereditary Colon Cancer Registry Center for Medical Genetics, Johns Hopkins Hospital, 600 North Wolfe Street, Baltimore, MD 21287-4922 Telephone: (410) 955-3875 Toll-free: (888) 939-3333
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International Cancer Alliance for Research and Education Address: International Cancer Alliance for Research and Education 4853 Cordell Avenue, Suite 11, Bethesda, MD 20814 Telephone: (301) 654-7933 Toll-free: (800) 422-7361 Fax: (301) 654-8684 Email:
[email protected] Web Site: http://icare.org Background: The International Cancer Alliance for Research and Education (ICARE) is a nonprofit organization that provides focused information to individuals affected by cancer and their physicians on an ongoing, person-to-person basis. Cancer is a general term referring to a group of diseases characterized by uncontrolled cellular growth that may invade surrounding tissues and spread (metastasize) to other bodily tissues or organs. The different cancers may be classified based upon the organ and cell type involved, the nature of the malignancy, and the disease's clinical course. ICARE has developed several patient-centered
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programs through a process of collection, evaluation, and dissemination of information, bringing affected individuals into contact with physicians and scientists from around the world. The Alliance is operated by a network of scientists, clinicians, staff members, and lay volunteers, many of whom are affected by cancer themselves. The Alliance maintains the ICARE Registry, a confidential membership listing that permits ongoing dialogue between ICARE and its network members. Registry members receive a 'cancer therapy review' including a description of the specific form of cancer in question, information concerning detection and staging procedures, an overview of current treatments, a bibliography for more in-depth research, and listings of diagnostic tests, ongoing clinical trials, and second opinion centers. Registry members also receive medical, research, clinical trial, and Food and Drug Administration (FDA) updates relating to the specific form of cancer or cancer in general; regular newsletters; and access to all ICARE programs. Such programs include ICARE patient education partner centers, which provide affected individuals with access to an electronic library of cancer information and online hook-ups at the community level; private electronic support groups for individuals dealing with common types of cancer or common issues; a clinical trial matching program; and other services. ICARE provides information concerning its mission, objectives, services, and programs on its web site on the Internet. ·
Intestinal Multiple Polyposis and Colorectal Cancer Registry Address: Intestinal Multiple Polyposis and Colorectal Cancer Registry P.O. Box 11, Conyngham, PA 18219 Telephone: (717) 788-3712 Toll-free: (888) 772-6566 Fax: (717) 788-4046 Email:
[email protected] Background: The Intestinal Multiple Polyposis and Colorectal Cancer Registry, also known as IMPACC, is a not-for-profit self-help service organization that was established in 1986. The purpose of the group is to provide information and support to people affected by Multiple Polyposis or Hereditary Colorectal Cancer, their families, and their physicians. Multiple Familial Polyposis is a group of rare inherited conditions of the gastrointestinal system characterized by benign growths (adenomatous polyps) lining the mucous membrane of the intestine. Because such growths have high malignant potential, affected individuals may potentially develop cancer of the colon and/or rectum. The Registry promotes ongoing medical research into the causes, treatment, and prevention of these disorders. IMPACC also offers a
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variety of services including genetic counseling, referrals to appropriate avenues of treatment, and a quarterly newsletter. ·
Johns Hopkins Hereditary Colorectal Cancer Registry Address: Johns Hopkins Hereditary Colorectal Cancer Registry 550 North Broadway, Number 108, Baltimore, MD 21205-2011 Telephone: (410) 955-3875 Toll-free: (888) 772-6566 Fax: (410) 614-9544 Email:
[email protected] Web Site: None Background: The Johns Hopkins Hereditary Colorectal Cancer Registry is a research organization that maintains a registry of families affected by different forms of Hereditary Colorectal Cancer including Hereditary Colon Cancer, Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer, Juvenile Polyposis, and Peutz-Jeghers Syndrome. Established in 1973, the Registry currently includes hundreds of families affected by these disorders. Interested individuals are offered the opportunity to participate in ongoing research studies. The Registry also offers educational materials to people affected by hereditary forms of colon cancer, their families, and physicians.
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M. D. Anderson Cancer Center Hereditary Colorectal Cancer Registry Address: M. D. Anderson Cancer Center Hereditary Colorectal Cancer Registry Universitiy of Texas, 1515 Holcombe Boulevard, Box 78, Houston, TX 77030 Telephone: (713) 792-2828 Toll-free: (800) 472-4376 Fax: (713) 745-1163 Email:
[email protected] Web Site: http://www.utmdacc.uth.tmc.edu/ Background: The University of Texas M.D. Anderson Cancer Center Hereditary Colorectal Cancer Registry is a registry organization dedicated to evaluating families in which there is a suspected or confirmed risk of a hereditary colorectal cancer syndrome. Established in 1988, the registry stafRegistry's staff makes arrangements to obtain necessary risk assessment, tests, procedures, or treatments at M.D. Anderson. Genetic testing and counseling are performed on appropriate families in order to identify persons at high risk for hereditary colorectal cancer. Individuals and their family members can also be evaluated for eligibility for other ongoing studies such as chemoprevention and
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psychosocial studies. Educational materials include a periodic newsletter entitled 'Hereditary Colon Cancer Newsletter,' a guide entitled 'Johns Hopkins Guide for Patients and Families: Familial Adenomatous Polyposis (FAP),' and 'Hereditary Non-Polyposis Colon Cancer: A Guide for Patients and Families.' Program activities include genetic counseling, educational programs, and referrals. The registry can be reached at its web site on the Internet at http://utmdacc.uth.tmc.edu. ·
OncoLink: The University of Pennsylvania Cancer Center Resource Address: The University of Pennsylvania Cancer Center Resource Web Site on the Internet, Telephone: (410) 955-3875 Toll-free: (888) 939-3333 Email:
[email protected] Web Site: http://www.oncolin.upenn.edu Background: OncoLink is a multimedia oncology information resource on the World Wide Web on the Internet. OncoLink's mission 'is consistent with that of the University of Pennsylvania Medical Center and the University of Pennsylvania Cancer Center, which have sanctioned the site's use and development. OncoLink is accessible worldwide to anyone with Internet access, and there is no charge for its use. Oncolink has been established with the following objectives: (1) dissemination of information relevant to the field of oncology; (2) education of health care personnel; (3) education of affected individuals, families, and other interested parties; and (4) rapid collection of information pertinent to the specialty. OncoLink's home page includes the following headings: Disease Oriented Headings (i.e., specific types of cancer); Medical Specialty Oriented Menus (i.e., medical specialities that deal with cancer, chemotherapy information, etc.); Psychosocial Support and Personal Experiences; Cancer Causes, Screening, and Prevention; Clinical Trials; Global Resources for Cancer Information; Cancer FAQs (frequently asked questions); Medical Supportive Care for the Cancer Patient; Conferences and Meetings; and Financial Issues for Cancer Patients.
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Roswell Park Family Cancer Registry Address: Roswell Park Family Cancer Registry Elm and Carlton Streets, Buffalo, NY 14263 Telephone: (716) 845-5815 Toll-free: (800) 685-6825 Fax: (716) 845-8980 Email:
[email protected]
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Background: Roswell Park Family Cancer Registry is a research organization dedicated to registering families at risk of developing cancers. The Registry seeks to educate affected individuals and family members in the areas of prevention, early detection, and treatment of cancer, as well as risk assessment of such family members. Established in 1992, this research program is designed to obtain detailed medical and family history information from people who, because of their family history or other risk factors, may have an increased potential of developing cancer. To this end, the Registry takes blood and other tissue samples. This material is provided to research scientists studying cancer genes. The affected individuals or families are thus provided with updated information on genetics, genetic cancers, and testing. The Registry produces educational materials including a pamphlet entitled 'Hereditary Non-polyposis Colorectal Cancer.' The organization supports such program activities as genetic counseling, patient and general education, and research. ·
Steve Antanas Stavro Familial Gastrointestinal Cancer Registry Address: Steve Antanas Stavro Familial Gastrointestinal Cancer Registry Familial Gastrointestinal Cancer Registry, Suite 1157, Mount Sinai Hospital, 600 University Avenue, Ontario, M5G 1X5, Canada Telephone: (416) 586-8334 Fax: (416) 586-8644 Email:
[email protected] Background: The Steve Antanas Stavro Familial Gastrointestinal Cancer Registry is a professional and research center dedicated to providing professional services as well as emotional support to people affected by familial gastrointestinal cancer and their families. Established in 1980, the center conducts research studies and has an investigative team focused on innovative surgical techniques related to gastrointestinal cancer. The center also has a molecular diagnostic program and offers a screening service for family members who may be at risk for the hereditary form of the disease. Along with its scientific and medical departments, the center also has a genetic counseling department that offers advice and support to affected individuals and families. The Steve Antanas Stavro Familial Gastrointestinal Cancer Registry maintains a database of affected individuals and produces educational and support materials including pamphlets, brochures, family guides, and a biannual newsletter. The Registry relays information regarding hospital and community resources through a patient library.
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Strang-Cornell Hereditary Colon Cancer Program Address: Strang-Cornell Hereditary Colon Cancer Program 428 East 72nd Street, New York, NY 10021 Telephone: (212) 746-5656 Toll-free: (888) 939-3333 Fax: (212) 746-8765 Email:
[email protected] Web Site: http://www.strang.org Background: The Strang-Cornell Hereditary Colon Cancer Program (SCPC) is a not- for-profit organization dedicated to providing individuals with Familial Adenomatous Polyposis (FAP) and Hereditary Nonpolyposis Colorectal Cancer (HNPCC) clinical and educational services, as well as to foster participation in research. Colorectal cancer is a common disease in the United States. While most cases of colorectal cancer are sporadic, up to ten percent are hereditary. Hereditary colorectal cancer includes the polyposis syndromes, of which Familial Adenomatious Polyposis is the most common, and the nonpolyposis syndromes, broadly referred to as Hereditary Nonpolyposis Colorectal Cancer. Established in 1934, this program is a collaboration between the Strang Cancer Prevention Center and the New York Hospital-Cornell Medical Center. SCPC includes three divisions: registries for FAP and HNPCC, which are maintained with the assistance of a full-time registrar; clinical and pre-clinical research, including the study of predictors of malignant potential, chemoprevention of colon cancer, gastrointestinal immune function, molecular diagnostics, and dietary intervention; and clinical services, inclusive of medical and surgical treatment, with specialists in nutrition, psychological and genetic counseling. Educational materials include two pamphlets entitled 'Nutrition Consultation Program' and 'Hereditary Colon Cancer Program.' Program activities include a support group, genetic counseling, patient networking, education, and referrals. SCPC can be reached at its e-mail address at MBERTAGatmail.med.cornell.edu or its web site at www.strang.org.
Finding More Associations There are a number of directories that list additional medical associations that you may find useful. While not all of these directories will provide different information than what is listed above, by consulting all of them, you will have nearly exhausted all sources for patient associations.
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The National Cancer Institute (NCI) The National Cancer Institute (NCI) has complied a list of national organizations that offer services to people with cancer and their families. To view the list, see the NCI fact sheet online at the following Web address: http://cis.nci.nih.gov/fact/8_1.htm. The name of each organization is accompanied by its contact information and a brief explanation of its services.
The National Health Information Center (NHIC) The National Health Information Center (NHIC) offers a free referral service to help people find organizations that provide information about colon cancer. For more information, see the NHIC’s Web site at http://www.health.gov/NHIC/ or contact an information specialist by calling 1-800-336-4797.
DIRLINE A comprehensive source of information on associations is the DIRLINE database maintained by the National Library of Medicine. The database comprises some 10,000 records of organizations, research centers, and government institutes and associations which primarily focus on health and biomedicine. DIRLINE is available via the Internet at the following Web site: http://dirline.nlm.nih.gov/. Simply type in “colon cancer” (or a synonym) or the name of a topic, and the site will list information contained in the database on all relevant organizations.
The Combined Health Information Database Another comprehensive source of information on healthcare associations is the Combined Health Information Database. Using the “Detailed Search” option, you will need to limit your search to “Organizations” and “colon cancer”. Type the following hyperlink into your Web browser: http://chid.nih.gov/detail/detail.html. To find associations, use the drop boxes at the bottom of the search page where “You may refine your search by.” For publication date, select “All Years.” Then, select your preferred language and the format option “Organization Resource Sheet.” By making these selections and typing in “colon cancer” (or synonyms) into the “For these words:” box, you will only receive results on organizations dealing
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with colon cancer. You should check back periodically with this database since it is updated every 3 months. The National Organization for Rare Disorders, Inc. The National Organization for Rare Disorders, Inc. has prepared a Web site that provides, at no charge, lists of associations organized by specific diseases. You can access this database at the following Web site: http://www.rarediseases.org/cgi-bin/nord/searchpage. Select the option called “Organizational Database (ODB)” and type “colon cancer” (or a synonym) in the search box.
Cancer Support Groups10 People diagnosed with cancer and their families face many challenges that may leave them feeling overwhelmed, afraid, and alone. It can be difficult to cope with these challenges or to talk to even the most supportive family members and friends. Often, support groups can help people affected by cancer feel less alone and can improve their ability to deal with the uncertainties and challenges that cancer brings. Support groups give people who are affected by similar diseases an opportunity to meet and discuss ways to cope with the illness. How Can Support Groups Help? People who have been diagnosed with cancer sometimes find they need assistance coping with the emotional as well as the practical aspects of their disease. In fact, attention to the emotional burden of cancer is sometimes part of a patient’s treatment plan. Cancer support groups are designed to provide a confidential atmosphere where cancer patients or cancer survivors can discuss the challenges that accompany the illness with others who may have experienced the same challenges. For example, people gather to discuss the emotional needs created by cancer, to exchange information about their disease—including practical problems such as managing side effects or returning to work after treatment—and to share their feelings. Support groups have helped thousands of people cope with these and similar situations.
10
This section has been adapted from the NCI: http://cis.nci.nih.gov/fact/8_8.htm.
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Can Family Members and Friends Participate in Support Groups? Family and friends are affected when cancer touches someone they love, and they may need help in dealing with stresses such as family disruptions, financial worries, and changing roles within relationships. To help meet these needs, some support groups are designed just for family members of people diagnosed with cancer; other groups encourage families and friends to participate along with the cancer patient or cancer survivor. How Can People Find Support Groups? Many organizations offer support groups for people diagnosed with cancer and their family members or friends. The NCI fact sheet National Organizations That Offer Services to People with Cancer and Their Families lists many cancer-concerned organizations that can provide information about support groups. This fact sheet is available at http://cis.nci.nih.gov/fact/8_1.htm on the Internet, or can be ordered from the Cancer Information Service at 1–800–4–CANCER (1–800–422–6237). Some of these organizations provide information on their Web sites about contacting support groups. Doctors, nurses, or hospital social workers who work with cancer patients may also have information about support groups, such as their location, size, type, and how often they meet. Most hospitals have social services departments that provide information about cancer support programs. Additionally, many newspapers carry a special health supplement containing information about where to find support groups.
What Types of Support Groups Are Available? Several kinds of support groups are available to meet the individual needs of people at all stages of cancer treatment, from diagnosis through follow-up care. Some groups are general cancer support groups, while more specialized groups may be for teens or young adults, for family members, or for people affected by a particular disease. Support groups may be led by a professional, such as a psychiatrist, psychologist, or social worker, or by cancer patients or survivors. In addition, support groups can vary in approach, size, and how often they meet. Many groups are free, but some require a fee (people can contact their health insurance company to find out whether their plan will cover the cost). It is important for people to find an atmosphere that is comfortable and meets their individual needs.
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Online Support Groups In addition to support groups, commercial Internet service providers offer forums and chat rooms for people with different illnesses and conditions. WebMDÒ, for example, offers such a service at their Web site: http://boards.webmd.com/roundtable. These online self-help communities can help you connect with a network of people whose concerns are similar to yours. Online support groups are places where people can talk informally. If you read about a novel approach, consult with your doctor or other healthcare providers, as the treatments or discoveries you hear about may not be scientifically proven to be safe and effective.
The Cancer Information Service11 The Cancer Information Service (CIS) is a program of the National Cancer Institute (NCI), the Nation’s lead agency for cancer research. As a resource for information and education about cancer, the CIS is a leader in helping people become active participants in their own health care by providing the latest information on cancer in understandable language. Through its network of regional offices, the CIS serves the United States, Puerto Rico, the U.S. Virgin Islands, and the Pacific Islands. For 25 years, the Cancer Information Service has provided the latest and most accurate cancer information to patients and families, the public, and health professionals by: ·
Interacting with people one-on-one through its Information Service,
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Working with organizations through its Partnership Program,
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Participating in research efforts to find the best ways to help people adopt healthier behaviors,
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Providing access to NCI information over the Internet. How Does the CIS Assist the Public?
Through the CIS toll-free telephone service (1–800–4–CANCER), callers speak with knowledgeable, caring staff who are experienced at explaining medical information in easy-to-understand terms. CIS information specialists answer calls in English and Spanish. They also provide cancer information to deaf and hard of hearing callers through the toll-free TTY number (1–800– 11
This section has been adapted from the NCI: http://cis.nci.nih.gov/fact/2_5.htm.
50 Colon Cancer
332–8615). CIS staff have access to comprehensive, accurate information from the NCI on a range of cancer topics, including the most recent advances in cancer treatment. They take as much time as each caller needs, provide thorough and personalized attention, and keep all calls confidential. The CIS also provides live, online assistance to users of NCI Web sites through LiveHelp, an instant messaging service that is available from 9:00 a.m. to 7:30 p.m. Eastern time, Monday through Friday. Through LiveHelp, information specialists provide answers to questions about cancer and help in navigating Cancer.gov, the NCI’s Web site. Through the telephone numbers or LiveHelp service, CIS users receive: ·
Answers to their questions about cancer, including ways to prevent cancer, symptoms and risks, diagnosis, current treatments, and research studies;
·
Written materials from the NCI;
·
Referrals to clinical trials and cancer-related services, such as treatment centers, mammography facilities, or other cancer organizations;
·
Assistance in quitting smoking from information specialists trained in smoking cessation counseling. What Kind of Assistance Does the CIS Partnership Program Offer?
Through its Partnership Program, the CIS collaborates with established national, state, and regional organizations to reach minority and medically underserved audiences with cancer information. Partnership Program staff provide assistance to organizations developing programs that focus on breast and cervical cancer, clinical trials, tobacco control, and cancer awareness for special populations. To reach those in need, the CIS: ·
Helps bring cancer information to people who do not traditionally seek health information or who may have difficulties doing so because of educational, financial, cultural, or language barriers;
·
Provides expertise to organizations to help strengthen their ability to inform people they serve about cancer; and
·
Links organizations with similar goals and helps them plan and evaluate programs, develop coalitions, conduct training on cancer-related topics, and use NCI resources.
Seeking Guidance 51
How Do CIS Research Efforts Assist the Public? The CIS plays an important role in research by studying the most effective ways to communicate with people about healthy lifestyles; health risks; and options for preventing, diagnosing, and treating cancer. The ability to conduct health communications research is a unique aspect of the CIS. Results from these research studies can be applied to improving the way the CIS communicates about cancer and can help other programs communicate more effectively. How Do People Reach the Cancer Information Service? ·
To speak with a CIS information specialist call 1–800–4–CANCER (1–800– 422–6237), 9:00 a.m. to 4:30 p.m. local time, Monday through Friday. Deaf or hard of hearing callers with TTY equipment may call 1–800–332–8615.
·
To obtain online assistance visit the NCI’s Cancer Information Web site at http://cancer.gov/cancer_information and click on the LiveHelp link between 9:00 a.m. and 7:30 p.m. Eastern time, Monday through Friday.
·
For information 24 hours a day, 7 days a week call 1–800–4–CANCER and select option 4 to hear recorded information at any time.
·
Visit NCI’s Web site at http://cancer.gov on the Internet.
·
Visit the CIS Web site at http://cancer.gov/cis on the Internet.
Finding Cancer Resources in Your Community12 If you have cancer or are undergoing cancer treatment, there are places in your community to turn to for help. There are many local organizations throughout the country that offer a variety of practical and support services to people with cancer. However, people often don’t know about these services or are unable to find them. National cancer organizations can assist you in finding these resources, and there are a number of things you can do for yourself. Whether you are looking for a support group, counseling, advice, financial assistance, transportation to and from treatment, or information about cancer, most neighborhood organizations, local health care providers, or area hospitals are a good place to start. Often, the hardest part of looking for help is knowing the right questions to ask. 12
Adapted from the NCI: http://cis.nci.nih.gov/fact/8_9.htm.
52 Colon Cancer
What Kind of Help Can I Get? Until now, you probably never thought about the many issues and difficulties that arise with a diagnosis of cancer. There are support services to help you deal with almost any type of problem that might occur. The first step in finding the help you need is knowing what types of services are available. The following pages describe some of these services and how to find them. ·
Information on Cancer. Most national cancer organizations provide a range of information services, including materials on different types of cancer, treatments, and treatment-related issues.
·
Counseling. While some people are reluctant to seek counseling, studies show that having someone to talk to reduces stress and helps people both mentally and physically. Counseling can also provide emotional support to cancer patients and help them better understand their illness. Different types of counseling include individual, group, family, self-help (sometimes called peer counseling), bereavement, patient-to-patient, and sexuality.
·
Medical Treatment Decisions. Often, people with cancer need to make complicated medical decisions. Many organizations provide hospital and physician referrals for second opinions and information on clinical trials (research studies with people), which may expand treatment options.
·
Prevention and Early Detection. While cancer prevention may never be 100 percent effective, many things (such as quitting smoking and eating healthy foods) can greatly reduce a person’s risk for developing cancer. Prevention services usually focus on smoking cessation and nutrition. Early detection services, which are designed to detect cancer when a person has no symptoms of disease, can include referrals for screening mammograms, Pap tests, or prostate exams.
·
Home Health Care. Home health care assists patients who no longer need to stay in a hospital or nursing home, but still require professional medical help. Skilled nursing care, physical therapy, social work services, and nutrition counseling are all available at home.
·
Hospice Care. Hospice is care focused on the special needs of terminally ill cancer patients. Sometimes called palliative care, it centers around providing comfort, controlling physical symptoms, and giving emotional support to patients who can no longer benefit from curative treatment. Hospice programs provide services in various settings, including the patient’s home, hospice centers, hospitals, or skilled nursing facilities. Your doctor or social worker can provide a referral for these services.
Seeking Guidance 53
·
Rehabilitation. Rehabilitation services help people adjust to the effects of cancer and its treatment. Physical rehabilitation focuses on recovery from the physical effects of surgery or the side effects associated with chemotherapy. Occupational or vocational therapy helps people readjust to everyday routines, get back to work, or find employment.
·
Advocacy. Advocacy is a general term that refers to promoting or protecting the rights and interests of a certain group, such as cancer patients. Advocacy groups may offer services to assist with legal, ethical, medical, employment, legislative, or insurance issues, among others. For instance, if you feel your insurance company has not handled your claim fairly, you may want to advocate for a review of its decision.
·
Financial. Having cancer can be a tremendous financial burden to cancer patients and their families. There are programs sponsored by the government and nonprofit organizations to help cancer patients with problems related to medical billing, insurance coverage, and reimbursement issues. There are also sources for financial assistance, and ways to get help collecting entitlements from Medicaid, Medicare, and the Social Security Administration.
·
Housing/Lodging. Some organizations provide lodging for the family of a patient undergoing treatment, especially if it is a child who is ill and the parents are required to accompany the child to treatment.
·
Children’s Services. A number of organizations provide services for children with cancer, including summer camps, make-a-wish programs, and help for parents seeking child care. How to Find These Services
Often, the services that people with cancer are looking for are right in their own neighborhood or city. The following is a list of places where you can begin your search for help. ·
The hospital, clinic, or medical center where you see your doctor, received your diagnosis, or where you undergo treatment should be able to give you information. Your doctor or nurse may be able to tell you about your specific medical condition, pain management, rehabilitation services, home nursing, or hospice care.
·
Most hospitals also have a social work, home care, or discharge planning department. This department may be able to help you find a support group, a nonprofit agency that helps people who have cancer, or the government agencies that oversee Social Security, Medicare, and
54 Colon Cancer
Medicaid. While you are undergoing treatment, be sure to ask the hospital about transportation, practical assistance, or even temporary child care. Talk to a hospital financial counselor in the business office about developing a monthly payment plan if you need help with hospital expenses. ·
The public library is an excellent source of information, as are patient libraries at many cancer centers. A librarian can help you find books and articles through a literature search.
·
A local church, synagogue, YMCA or YWCA, or fraternal order may provide financial assistance, or may have volunteers who can help with transportation and home care. Catholic Charities, the United Way, or the American Red Cross may also operate local offices. Some of these organizations may provide home care, and the United Way’s information and referral service can refer you to an agency that provides financial help. To find the United Way serving your community, visit their online directory at http://www.unitedway.org on the Internet or look in the White Pages of your local telephone book.
·
Local or county government agencies may offer low-cost transportation (sometimes called para-transit) to individuals unable to use public transportation. Most states also have an Area Agency on Aging that offers low-cost services to people over 60. Your hospital or community social worker can direct you to government agencies for entitlements, including Social Security, state disability, Medicaid, income maintenance, and food stamps. (Keep in mind that most applications to entitlement programs take some time to process.) The Federal government also runs the Hill-Burton program (1–800–638–0742), which funds certain medical facilities and hospitals to provide cancer patients with free or low-cost care if they are in financial need. Getting the Most From a Service: What To Ask
No matter what type of help you are looking for, the only way to find resources to fit your needs is to ask the right questions. When you are calling an organization for information, it is important to think about what questions you are going to ask before you call. Many people find it helpful to write out their questions in advance, and to take notes during the call. Another good tip is to ask the name of the person with whom you are speaking in case you have follow-up questions. Below are some of the questions you may want to consider if you are calling or visiting a new agency and want to learn about how they can help:
Seeking Guidance 55
·
How do I apply [for this service]?
·
Are there eligibility requirements? What are they?
·
Is there an application process? How long will it take? What information will I need to complete the application process? Will I need anything else to get the service?
·
Do you have any other suggestions or ideas about where I can find help?
The most important thing to remember is that you will rarely receive help unless you ask for it. In fact, asking can be the hardest part of getting help. Don’t be afraid or ashamed to ask for assistance. Cancer is a very difficult disease, but there are people and services that can ease your burdens and help you focus on your treatment and recovery.
Finding Doctors Who Specialize in Cancer Care13 One of the most important aspects of your treatment will be the relationship between you and your doctor or specialist. All patients with colon cancer must go through the process of selecting a physician. A common way to find a doctor who specializes in cancer care is to ask for a referral from your primary care physician. Sometimes, you may know a specialist yourself, or through the experience of a family member, coworker, or friend. The following resources may also be able to provide you with names of doctors who specialize in treating specific diseases or conditions. However, these resources may not have information about the quality of care that the doctors provide. ·
Your local hospital or its patient referral service may be able to provide you with a list of specialists who practice at that hospital.
·
Your nearest National Cancer Institute (NCI)-designated cancer center can provide information about doctors who practice at that center. The NCI fact sheet The National Cancer Institute Cancer Centers Program describes and gives contact information, including Web sites, for NCIdesignated cancer treatment centers around the country. Many of the cancer centers’ Web sites have searchable directories of physicians who practice at each facility. The NCI’s fact sheet is available at http://cis.nci.nih.gov/fact/1_2.htm on the Internet, or by calling the Cancer Information Service (CIS) at 1–800–4–CANCER (1–800–422–6237).
13
Adapted from the NCI: http://cis.nci.nih.gov/fact/7_47.htm.
56 Colon Cancer
·
The American Board of Medical Specialties (ABMS) publishes a list of board-certified physicians. The Official ABMS Directory of Board Certified Medical Specialists lists doctors’ names along with their specialty and their educational background. This resource is available in most public libraries. The ABMS also has a Web site that can be used to verify whether a specific physician is board-certified. This free service is located at http://www.abms.org/newsearch.asp on the Internet. Verification of a physician’s board certification can also be obtained by calling the ABMS at 1–866–275–2267 (1–866–ASK–ABMS).
·
The American Medical Association (AMA) provides an online service called AMA Physician Select that offers basic professional information on virtually every licensed physician in the United States and its possessions. The database can be searched by doctor’s name or by medical specialty. The AMA Physician Select service is located at http://www.ama-assn.org/aps/amahg.htm on the Internet.
·
The American Society of Clinical Oncologists (ASCO) provides an online list of doctors who are members of ASCO. The member database has the names and affiliations of over 15,000 oncologists worldwide. It can be searched by doctor’s name, institution’s name, location, and/or type of board certification. This service is located at http://www.asco.org/people/db/html/m_db.htm on the Internet.
·
The American College of Surgeons (ACOS) Fellowship Database is an online list of surgeons who are Fellows of the ACOS. The list can be searched by doctor’s name, geographic location, or medical specialty. This service is located at http://web.facs.org/acsdir/default.htm on the Internet. The ACOS can be contacted at 633 North Saint Clair Street, Chicago, IL 60611–3211; or by telephone at 312–202–5000.
·
Local medical societies may maintain lists of doctors in each specialty.
·
Public and medical libraries may have print directories of doctors’ names, listed geographically by specialty.
·
Your local Yellow Pages may have doctors listed by specialty under “Physicians.”
The Agency for Healthcare Research and Quality (AHRQ) offers Your Guide to Choosing Quality Health Care, which has information for consumers on choosing a health plan, a doctor, a hospital, or a long-term care provider. The Guide includes suggestions and checklists that you can use to determine which doctor or hospital is best for you. This resource is available at http://www.ahrq.gov/consumer/qntool.htm on the Internet. You can also
Seeking Guidance 57
order the Guide by calling the AHRQ Publications Clearinghouse at 1–800– 358–9295. If you are a member of a health insurance plan, your choice may be limited to doctors who participate in your plan. Your insurance company can provide you with a list of participating primary care doctors and specialists. It is important to ask your insurance company if the doctor you choose is accepting new patients through your health plan. You also have the option of seeing a doctor outside your health plan and paying the costs yourself. If you have a choice of health insurance plans, you may first wish to consider which doctor or doctors you would like to use, then choose a plan that includes your chosen physician(s). The National Comprehensive Cancer Network (NCCN) Physician Directory lists specialists who practice in the NCCN’s 19 member institutions across the U.S. To access the directory, go to http://www.nccn.org/ and click on “Physician Directory“. To use this service, you will be required to scroll to the bottom of the page and select “I agree.” Enter your search criteria and select “Find” at the bottom of the page. To obtain more information on a physician or institution, contact the institution’s Physician Referral Department or the NCCN Patient Information and Referral Service at 1-888909-NCCN or
[email protected]. If the previous sources did not meet your needs, you may want to log on to the Web site of the National Organization for Rare Disorders (NORD) at http://www.rarediseases.org/. NORD maintains a database of doctors with expertise in various rare diseases. The Metabolic Information Network (MIN), 800-945-2188, also maintains a database of physicians with expertise in various metabolic diseases.
Selecting Your Doctor14 There are many factors to consider when choosing a doctor. To make the most informed decision, you may wish to speak with several doctors before choosing one. When you meet with each doctor, you might want to consider the following: ·
Does the doctor have the education and training to meet my needs?
·
Does the doctor use the hospital that I have chosen?
14 This
section has been adapted from the AHRQ: http://www.ahrq.gov/consumer/qntascii/qntdr.htm
58 Colon Cancer
·
Does the doctor listen to me and treat me with respect?
·
Does the doctor explain things clearly and encourage me to ask questions?
·
What are the doctor’s office hours?
·
Who covers for the doctor when he or she is unavailable? Will that person have access to my medical records?
·
How long does it take to get an appointment with the doctor?
If you are choosing a surgeon, you may wish to ask additional questions about the surgeon’s background and experience with specific procedures. These questions may include: ·
Is the surgeon board-certified?15
·
Has the surgeon been evaluated by a national professional association of surgeons, such as the American College of Surgeons (ACOS)?
·
At which treatment facility or facilities does the surgeon practice?
·
How often does the surgeon perform the type of surgery I need?
·
How many of these procedures has the surgeon performed? What was the success rate?
It is important for you to feel comfortable with the specialist that you choose, because you will be working closely with that person to make decisions about your cancer treatment. Trust your own observations and feelings when deciding on a doctor for your medical care. Other health professionals and support services may also be important during cancer treatment. The National Cancer Institute fact sheet Your Health Care Team: Your Doctor Is Only the Beginning has information about these providers and services, and how to locate them. This fact sheet is located at http://cis.nci.nih.gov/fact/8_10.htm on the Internet, or can be obtained by calling the CIS at 1–800–4–CANCER (1–800–422–6237).
While board certification is a good measure of a doctor’s knowledge, it is possible to receive quality care from doctors who are not board certified. 15
Seeking Guidance 59
Working with Your Doctor16 Research has shown that patients who have good relationships with their doctors tend to be more satisfied with their care and have better results. Here are some tips to help you and your doctor become partners: ·
You know important things about your symptoms and your health history. Tell your doctor what you think he or she needs to know.
·
It is important to tell your doctor personal information, even if it makes you feel embarrassed or uncomfortable.
·
Bring a “health history” list with you (and keep it up to date).
·
Always bring any medications you are currently taking with you to the appointment, or you can bring a list of your medications including dosage and frequency information. Talk about any allergies or reactions you have had to your medications.
·
Tell your doctor about any natural or alternative medicines you are taking.
·
Bring other medical information, such as x-ray films, test results, and medical records.
·
Ask questions. If you don’t, your doctor will assume that you understood everything that was said.
·
Write down your questions before your visit. List the most important ones first to make sure that they are addressed.
·
Consider bringing a friend with you to the appointment to help you ask questions. This person can also help you understand and/or remember the answers.
·
Ask your doctor to draw pictures if you think that this would help you understand.
·
Take notes. Some doctors do not mind if you bring a tape recorder to help you remember things, but always ask first.
·
Let your doctor know if you need more time. If there is not time that day, perhaps you can speak to a nurse or physician assistant on staff or schedule a telephone appointment.
·
Take information home. Ask for written instructions. Your doctor may also have brochures and audio and videotapes that can help you.
This section has been adapted from the AHRQ: www.ahrq.gov/consumer/qntascii/qntdr.htm.
16
60 Colon Cancer
·
After leaving the doctor’s office, take responsibility for your care. If you have questions, call. If your symptoms get worse or if you have problems with your medication, call. If you had tests and do not hear from your doctor, call for your test results. If your doctor recommended that you have certain tests, schedule an appointment to get them done. If your doctor said you should see an additional specialist, make an appointment.
By following these steps, you will enhance the relationship you will have with your physician.
Finding a Cancer Treatment Facility17 Choosing a treatment facility is another important consideration for getting the best medical care possible. Although you may not be able to choose which hospital treats you in an emergency, you can choose a facility for scheduled and ongoing care. If you have already found a doctor for your cancer treatment, you may need to choose a facility based on where your doctor practices. Your doctor may be able to recommend a facility that provides quality care to meet your needs. You may wish to ask the following questions when considering a treatment facility: ·
Has the facility had experience and success in treating my condition?
·
Has the facility been rated by state, consumer, or other groups for its quality of care?
·
How does the facility check and work to improve its quality of care?
·
Has the facility been approved by a nationally recognized accrediting body, such as the American College of Surgeons (ACOS) and/or the Joint Commission on Accredited Healthcare Organizations (JCAHO)?
·
Does the facility explain patients’ rights and responsibilities? Are copies of this information available to patients?
·
Does the treatment facility offer support services, such as social workers and resources to help me find financial assistance if I need it?
·
Is the facility conveniently located?
If you are a member of a health insurance plan, your choice of treatment facilities may be limited to those that participate in your plan. Your Adapted from the NCI: http://cis.nci.nih.gov/fact/7_47.htm. At this Web site, information on how to find treatment facilities is also available for patients living outside the U.S. 17
Seeking Guidance 61
insurance company can provide you with a list of approved facilities. Although the costs of cancer treatment can be very high, you have the option of paying out-of-pocket if you want to use a treatment facility that is not covered by your insurance plan. If you are considering paying for treatment yourself, you may wish to discuss the potential costs with your doctor beforehand. You may also want to speak with the person who does the billing for the treatment facility. In some instances, nurses and social workers can provide you with more information about coverage, eligibility, and insurance issues. The following resources may help you find a hospital or treatment facility for your care: ·
The NCI fact sheet The National Cancer Institute Cancer Centers Program describes and gives contact information for NCI-designated cancer treatment centers around the country.
·
The ACOS accredits cancer programs at hospitals and other treatment facilities. More than 1,400 programs in the United States have been designated by the ACOS as Approved Cancer Programs. The ACOS Web site offers a searchable database of these programs at http://web.facs.org/cpm/default.htm on the Internet. The ACOS can be contacted at 633 North Saint Clair Street, Chicago, IL 60611–3211; or by telephone at 312–202–5000.
·
The JCAHO is an independent, not-for-profit organization that evaluates and accredits health care organizations and programs in the United States. It also offers information for the general public about choosing a treatment facility. The JCAHO Web site is located at http://www.jcaho.org on the Internet. The JCAHO is located at One Renaissance Boulevard, Oakbrook Terrace, IL 60181–4294. The telephone number is 630–792–5800.
·
The JCAHO offers an online Quality Check service that patients can use to determine whether a specific facility has been accredited by the JCAHO and view the organization’s performance reports. This service is located at http://www.jcaho.org/qualitycheck/directry/directry.asp on the Internet.
·
The AHRQ publication Your Guide To Choosing Quality Health Care has suggestions and checklists for choosing the treatment facility that is right for you.
62 Colon Cancer
Additional Cancer Support Information In addition to the references above, the NCI has set up guidance Web sites that offers information on issues relating to cancer. These include: ·
Facing Forward - A Guide for Cancer Survivors: http://www.cancer.gov/cancer_information/doc_img.aspx?viewid=cc93a 843-6fc0-409e-8798-5c65afc172fe
·
Taking Time: Support for People With Cancer and the People Who Care About Them: http://www.cancer.gov/cancer_information/doc_img.aspx?viewid=21a4 6445-a5c8-4fee-95a3-d9d0d665077a
·
When Cancer Recurs: Meeting the Challenge: http://www.cancer.gov/cancer_information/doc_img.aspx?viewid=9e13 d0d2-b7de-4bd6-87da-5750300a0dab
·
Your Health Care Team: Your Doctor Is Only the Beginning: http://cis.nci.nih.gov/fact/8_10.htm
Vocabulary Builder The following vocabulary builder provides definitions of words used in this chapter that have not been defined in previous chapters: Abscess: A localized collection of pus caused by suppuration buried in tissues, organs, or confined spaces. [EU] Anorectal: Pertaining to the anus and rectum or to the junction region between the two. [EU] Bereavement: Refers to the whole process of grieving and mourning and is associated with a deep sense of loss and sadness. [NIH] Bladder: The organ that stores urine. [NIH] Cervical: Relating to the neck, or to the neck of any organ or structure. Cervical lymph nodes are located in the neck; cervical cancer refers to cancer of the uterine cervix, which is the lower, narrow end (the "neck") of the uterus. [NIH] Charities: Social welfare organizations with programs designed to assist individuals in times of need. [NIH] Chemoprevention: The use of drugs, vitamins, or other agents to try to reduce the risk of, or delay the development or recurrence of, cancer. [NIH] Curative: Tending to overcome disease and promote recovery. [EU]
Seeking Guidance 63
Fissure: Any cleft or groove, normal or otherwise; especially a deep fold in the cerebral cortex which involves the entire thickness of the brain wall. [EU] Fistula: An abnormal passage or communication, usually between two internal organs, or leading from an internal organ to the surface of the body; frequently designated according to the organs or parts with which it communicates, as anovaginal, brochocutaneous, hepatopleural, pulmonoperitoneal, rectovaginal, urethrovaginal, and the like. Such passages are frequently created experimentally for the purpose of obtaining body secretions for physiologic study. [EU] Hemorrhoid: An enlarged or swollen blood vessel, usually located near the anus or the rectum. [NIH] Incontinence: Inability to control the flow of urine from the bladder (urinary incontinence) or the escape of stool from the rectum (fecal incontinence). [NIH] Leukemia: Cancer of blood-forming tissue. [NIH] Lymphoma: Cancer that arises in cells of the lymphatic system. [NIH] Malignancy: A cancerous tumor that can invade and destroy nearby tissue and spread to other parts of the body. [NIH] Mammogram: An x-ray of the breast. [NIH] Mammography: The use of x-rays to create a picture of the breast. [NIH] Melanoma: A form of skin cancer that arises in melanocytes, the cells that produce pigment. Melanoma usually begins in a mole. [NIH] Membrane: A very thin layer of tissue that covers a surface. [NIH] Metastasize: To spread from one part of the body to another. When cancer cells metastasize and form secondary tumors, the cells in the metastatic tumor are like those in the original (primary) tumor. [NIH] Molecular: Of, pertaining to, or composed of molecules : a very small mass of matter. [EU] Neoplasm: A new growth of benign or malignant tissue. [NIH] Oncologist: A doctor who specializes in treating cancer. Some oncologists specialize in a particular type of cancer treatment. For example, a radiation oncologist specializes in treating cancer with radiation. [NIH] Otolaryngology: A surgical specialty concerned with the study and treatment of disorders of the ear, nose, and throat. [NIH] Pancreatic: Having to do with the pancreas. [NIH] Pap test: The collection of cells from the cervix for examination under a microscope. It is used to detect changes that may be cancer or may lead to cancer, and can show noncancerous conditions, such as infection or
64 Colon Cancer
inflammation. Also called a Pap smear. [NIH] Prolapse: 1. the falling down, or sinking, of a part or viscus; procidentia. 2. to undergo such displacement. [EU] Prostate: A gland in males that surrounds the neck of the bladder and the urethra. It secretes a substance that liquifies coagulated semen. It is situated in the pelvic cavity behind the lower part of the pubic symphysis, above the deep layer of the triangular ligament, and rests upon the rectum. [NIH] Radiologist: A doctor who specializes in creating and interpreting pictures of areas inside the body. The pictures are produced with x-rays, sound waves, or other types of energy. [NIH] Registries: The systems and processes involved in the establishment, support, management, and operation of registers, e.g., disease registers. [NIH] Sporadic: Neither endemic nor epidemic; occurring occasionally in a random or isolated manner. [EU] Thoracic: Having to do with the chest. [NIH] Thyroid: A gland located near the windpipe (trachea) that produces thyroid hormone, which helps regulate growth and metabolism. [NIH] Urology: A surgical specialty concerned with the study, diagnosis, and treatment of diseases of the urinary tract in both sexes and the genital tract in the male. It includes the specialty of andrology which addresses both male genital diseases and male infertility. [NIH] Wart: A raised growth on the surface of the skin or other organ. [NIH]
Clinical Trials 65
CHAPTER 3. CLINICAL TRIALS AND COLON CANCER Overview Very few medical conditions have a single treatment. The basic treatment guidelines that your physician has discussed with you, or those that you have found using the techniques discussed in Chapter 1, may provide you with all that you will require. For some patients, current treatments can be enhanced with new or innovative techniques currently under investigation. In this chapter, we will describe how clinical trials work and show you how to keep informed of trials concerning colon cancer.
What Is a Clinical Trial?18 Clinical trials involve the participation of people in medical research. Most medical research begins with studies in test tubes and on animals. Treatments that show promise in these early studies may then be tried with people. The only sure way to find out whether a new treatment is safe, effective, and better than other treatments for colon cancer is to try it on patients in a clinical trial.
The discussion in this chapter has been adapted from the NIH and the NEI: www.nei.nih.gov/netrials/ctivr.htm.
18
66 Colon Cancer
What Kinds of Clinical Trials Are There? Clinical trials are carried out in three phases: ·
Phase I. Researchers first conduct Phase I trials with small numbers of patients and healthy volunteers. If the new treatment is a medication, researchers also try to determine how much of it can be given safely.
·
Phase II. Researchers conduct Phase II trials in small numbers of patients to find out the effect of a new treatment on colon cancer.
·
Phase III. Finally, researchers conduct Phase III trials to find out how new treatments for colon cancer compare with standard treatments already being used. Phase III trials also help to determine if new treatments have any side effects. These trials--which may involve hundreds, perhaps thousands, of people--can also compare new treatments with no treatment. How Is a Clinical Trial Conducted?
Various organizations support clinical trials at medical centers, hospitals, universities, and doctors’ offices across the United States. The “principal investigator” is the researcher in charge of the study at each facility participating in the clinical trial. Most clinical trial researchers are medical doctors, academic researchers, and specialists. The “clinic coordinator” knows all about how the study works and makes all the arrangements for your visits. All doctors and researchers who take part in the study on colon cancer carefully follow a detailed treatment plan called a protocol. This plan fully explains how the doctors will treat you in the study. The “protocol” ensures that all patients are treated in the same way, no matter where they receive care. Clinical trials are controlled. This means that researchers compare the effects of the new treatment with those of the standard treatment. In some cases, when no standard treatment exists, the new treatment is compared with no treatment. Patients who receive the new treatment are in the treatment group. Patients who receive a standard treatment or no treatment are in the “control” group. In some clinical trials, patients in the treatment group get a new medication while those in the control group get a placebo. A placebo is a harmless substance, a “dummy” pill, that has no effect on colon cancer. In other clinical trials, where a new surgery or device (not a medicine) is being tested, patients in the control group may receive a “sham treatment.” This
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treatment, like a placebo, has no effect on colon cancer and does not harm patients. Researchers assign patients “randomly” to the treatment or control group. This is like flipping a coin to decide which patients are in each group. If you choose to participate in a clinical trial, you will not know which group you will be appointed to. The chance of any patient getting the new treatment is about 50 percent. You cannot request to receive the new treatment instead of the placebo or sham treatment. Often, you will not know until the study is over whether you have been in the treatment group or the control group. This is called a “masked” study. In some trials, neither doctors nor patients know who is getting which treatment. This is called a “double masked” study. These types of trials help to ensure that the perceptions of the patients or doctors will not affect the study results. Natural History Studies Unlike clinical trials in which patient volunteers may receive new treatments, natural history studies provide important information to researchers on how colon cancer develops over time. A natural history study follows patient volunteers to see how factors such as age, sex, race, or family history might make some people more or less at risk for colon cancer. A natural history study may also tell researchers if diet, lifestyle, or occupation affects how a disease or disorder develops and progresses. Results from these studies provide information that helps answer questions such as: How fast will a disease or disorder usually progress? How bad will the condition become? Will treatment be needed? What Is Expected of Patients in a Clinical Trial? Not everyone can take part in a clinical trial for a specific disease or disorder. Each study enrolls patients with certain features or eligibility criteria. These criteria may include the type and stage of disease or disorder, as well as, the age and previous treatment history of the patient. You or your doctor can contact the sponsoring organization to find out more about specific clinical trials and their eligibility criteria. If you are interested in joining a clinical trial, your doctor must contact one of the trial’s investigators and provide details about your diagnosis and medical history. If you participate in a clinical trial, you may be required to have a number of medical tests. You may also need to take medications and/or undergo
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surgery. Depending upon the treatment and the examination procedure, you may be required to receive inpatient hospital care. Or, you may have to return to the medical facility for follow-up examinations. These exams help find out how well the treatment is working. Follow-up studies can take months or years. However, the success of the clinical trial often depends on learning what happens to patients over a long period of time. Only patients who continue to return for follow-up examinations can provide this important long-term information.
Recent Trials on Colon Cancer The National Institutes of Health and other organizations sponsor trials on various diseases and disorders. Because funding for research goes to the medical areas that show promising research opportunities, it is not possible for the NIH or others to sponsor clinical trials for every disease and disorder at all times. The following lists recent trials dedicated to colon cancer.19 If the trial listed by the NIH is still recruiting, you may be eligible. If it is no longer recruiting or has been completed, then you can contact the sponsors to learn more about the study and, if published, the results. Further information on the trial is available at the Web site indicated. Please note that some trials may no longer be recruiting patients or are otherwise closed. Before contacting sponsors of a clinical trial, consult with your physician who can help you determine if you might benefit from participation. ·
Antineoplaston Therapy in Treating Patients With Metastatic or Unresectable Colon Cancer Condition(s): recurrent colon adenocarcinoma of the colon
cancer;
stage
IV
colon
cancer;
Study Status: This study is currently recruiting patients. Sponsor(s): Burzynski Research Institute Purpose - Excerpt: RATIONALE: Antineoplastons are naturally occurring substances found in urine. Antineoplastons may inhibit the growth of cancer cells. PURPOSE: Phase II trial to study the effectiveness of antineoplaston therapy in treating patients with metastatic or unresectable colon cancer. Phase(s): Phase II Study Type: Treatment Contact(s): Texas; Burzynski Research Institute, Houston, Texas, 77055, United States; Recruiting; Stanislaw R. Burzynski 713-335-5697. Study 19
These are listed at www.ClinicalTrials.gov.
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chairs or principal investigators: Stanislaw R. Burzynski, Study Chair; Burzynski Research Institute Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00003485;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
BMS-247550 in Treating Patients With Metastatic Colorectal Cancer Condition(s): recurrent colon cancer; adenocarcinoma of the rectum; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); UAB Comprehensive Cancer Center Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have metastatic colorectal cancer. Phase(s): Phase II Study Type: Treatment Contact(s): Alabama; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35294-3300, United States; Recruiting; Andres Forero-Torres 205-975-2837; Georgia; Georgia Cancer Specialists, Atlanta, Georgia, 30342, United States; Recruiting; Mansoor Noorali Saleh 205-975-9025. Study chairs or principal investigators: Andres Forero-Torres, Study Chair; UAB Comprehensive Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00033306;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer Condition(s): recurrent colon cancer; adenocarcinoma of the rectum; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); University of Chicago Cancer Research Center
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Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have recurrent or metastatic colorectal cancer. Phase(s): Phase II Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00022477;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer Condition(s): recurrent colon cancer; adenocarcinoma of the rectum; stage III colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): Hoffmann-La Roche Ltd Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer. Phase(s): Phase II Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00022698;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Combination Chemotherapy After Surgery in Treating Patients With Liver Metastases From Colorectal Cancer Condition(s): adenocarcinoma of the rectum; liver metastases; stage IV rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients.
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Sponsor(s): National Cancer Institute (NCI); Memorial Sloan-Kettering Cancer Center Purpose - Excerpt: RATIONALE: Surgery may be an effective therapy in treating patients with liver metastases. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy given after surgery in treating patients who have liver metastases from colorectal cancer. Phase(s): Phase I; Phase II Study Type: Treatment Contact(s): New York; Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting; Nancy E. Kemeny 212639-8068. Study chairs or principal investigators: Nancy E. Kemeny, Study Chair; Memorial Sloan-Kettering Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00003753;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer Condition(s): recurrent colon cancer; stage III colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI) Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Clinical trial to study the effectiveness of combination chemotherapy in treating patients who have advanced colorectal cancer. Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00039611;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Combination Chemotherapy in Treating Patients With Colon Cancer Condition(s): stage III colon cancer; stage II colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): Groupe Regional d'Etudes du Cancer Colorectal - Belgium Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether the time a drug is given improves its effectiveness in treating colon cancer. PURPOSE: Randomized phase III trial to determine the best time to give carboplatin with fluorouracil and leucovorin in treating patients who have stage IIB or stage III colon cancer. Phase(s): Phase III Study Type: Treatment Contact(s): Belgium; Centre Hospitalier Hutois, Huy, 4500, Belgium; Recruiting; Jean Bury 085--27-2005; Les Cliniques Saint-Joseph ASBL, Liege (Luik), B 4000, Belgium; Recruiting; Christian N.J. Focan 00-32-4224-8990. Study chairs or principal investigators: Christian N.J. Focan, Study Chair; Groupe Regional d'Etudes du Cancer Colorectal - Belgium Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00046995;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Combination Chemotherapy in Treating Patients With Colorectal Cancer Condition(s): recurrent colon cancer; stage III colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer Study Status: This study is currently recruiting patients. Sponsor(s): EORTC Chronotherapy Study Group Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at the time of day that allows for the best drug response may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Randomized phase II trial to determine the best time to give irinotecan combined with fluorouracil, leucovorin, and oxaliplatin in treating patients who have colorectal cancer. Phase(s): Phase II
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Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00039208;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Combination Chemotherapy in Metastases from Colorectal Cancer
Treating
Patients
With
Liver
Condition(s): recurrent colon cancer; stage IV rectal cancer; adenocarcinoma of the rectum; recurrent rectal cancer; liver metastases; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Eastern Cooperative Oncology Group; Cancer and Leukemia Group B Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective for metastatic colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of intrahepatic floxuridine, leucovorin, and dexamethasone with that of systemic fluorouracil and leucovorin in treating patients who have unresectable liver metastases from colorectal cancer. Phase(s): Phase III Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002716;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer Condition(s): recurrent colon cancer; adenocarcinoma of the rectum; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Cancer and Leukemia Group B
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Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus trastuzumab in treating patients who have advanced, recurrent, or metastatic colorectal cancer. Phase(s): Phase II Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00006015;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated Condition(s): recurrent colon cancer; adenocarcinoma of the rectum; stage III colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Eastern Cooperative Oncology Group Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor cells. It is not yet known if bevacizumab is more effective with or without combination chemotherapy in treating colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bevacizumab to that of bevacizumab alone in treating patients who have advanced or metastatic colorectal cancer that has been previously treated. Phase(s): Phase III Study Type: Treatment Contact(s): see Web site below
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Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00025337;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Combination Chemotherapy With or Without Chemoembolization in Treating Patients With Colorectal Cancer Metastatic to the Liver Condition(s): recurrent colon cancer; adenocarcinoma of the rectum; liver metastases; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); American College of Radiology Imaging Network Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. One way to give chemotherapy drugs is by chemoembolization, which kills tumor cells by delivering drugs directly into the tumor and then blocking the blood flow to the tumor. It is not yet known if chemoembolization is more effective than standard chemotherapy in treating metastatic cancer. PURPOSE: Phase I trial and randomized phase III trial to determine the effectiveness of chemoembolization in treating patients who have colorectal cancer metastatic to the liver. For the phase III part of the trial, patients will be randomly assigned to one of two groups. Patients in group one will receive chemotherapy once a week for 4 weeks. Treatment may be repeated every 6 weeks for as long as benefit is shown. Patients in group two will receive chemotherapy as in group one and will undergo chemoembolization on day 36. The chemotherapy may be repeated as in group one. Chemoembolization may be repeated every 6 weeks for up to four courses. Patients will be evaluated every 3 months for 2 years, every 6 months for 3 years, and once a year thereafter. Phase(s): Phase I; Phase III Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00023868;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Combination Chemotherapy With or Without Cryosurgery in Treating Patients With Liver Metastases from Colorectal Cancer Condition(s): adenocarcinoma of the rectum; liver metastases; stage IV rectal cancer; stage IV colon cancer; adenocarcinoma of the colon
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Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Memorial Sloan-Kettering Cancer Center Purpose - Excerpt: RATIONALE: Cryosurgery kills cancer cells by freezing them. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with cryosurgery and giving drugs in different ways may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of intrahepatic and intravenous combination chemotherapy with or without cryosurgery in treating liver metastases from colorectal cancer. Phase(s): Phase I Study Type: Treatment Contact(s): New York; Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting; Nancy E. Kemeny 212639-8068. Study chairs or principal investigators: Nancy E. Kemeny, Study Chair; Memorial Sloan-Kettering Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00008294;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer Condition(s): stage III colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer; Fondation Francaise de Cancerologie Digestive Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without irinotecan in treating colon cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without irinotecan in treating patients who have stage III colon cancer. Phase(s): Phase III Study Type: Treatment Contact(s): see Web site below
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Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00005979;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Comparing Two Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer Condition(s): recurrent colon cancer; adenocarcinoma of the rectum; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): GERCOR Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for metastatic colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have metastatic colorectal cancer. Phase(s): Phase III Study Type: Treatment Contact(s): France; Hopital Saint Antoine, Paris, 75571, France; Recruiting; Aimery De Gramont 33-1-49282336. Study chairs or principal investigators: Aimery De Gramont, Study Chair; GERCOR Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00006468;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer Condition(s): colon cancer; rectal cancer; screening for colorectal cancer Study Status: This study is currently recruiting patients. Sponsor(s): Duke Comprehensive Cancer Center Purpose - Excerpt: RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer. New diagnostic procedures such as computed tomographic colonography may provide a less invasive method of identifying patients who have colon cancer. PURPOSE: Diagnostic and screening trial to compare the effectiveness of barium enema, computed tomographic colonography, and colonoscopy in detecting of colon cancer.
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Study Type: Screening, Diagnostic Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00016029;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer Condition(s): stage III rectal cancer; stage IV rectal cancer; stage I rectal cancer; stage I colon cancer; stage II colon cancer; stage 0 rectal cancer; stage II rectal cancer; stage III colon cancer; stage IV colon cancer; stage 0 colon cancer Study Status: This study is currently recruiting patients. Sponsor(s): Medical Research Council Purpose - Excerpt: RATIONALE: Laparoscopic-assisted surgery is a less invasive type of surgery for colorectal cancer and may have fewer side effects and improve recovery. It is not yet known if undergoing conventional surgery is more effective than laparoscopic-assisted surgery for colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of conventional surgery with that of laparoscopicassisted surgery in treating patients who have colorectal cancer. Phase(s): Phase III Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00003354;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Curcumin for the Prevention of Colon Cancer Condition(s): prevention of colorectal cancer; colon cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); University of Michigan Comprehensive Cancer Center Purpose - Excerpt: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Curcumin may be effective in preventing the development of colon cancer. PURPOSE: Phase I trial to determine the dose amount of curcumin that can be tolerated to help in preventing colon cancer in healthy men and women.
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Phase(s): Phase I Study Type: Prevention Contact(s): Michigan; University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0752, United States; Recruiting; Dean E. Brenner 734-647-1417. Study chairs or principal investigators: Dean E. Brenner, Study Chair; University of Michigan Comprehensive Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00027495;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer Condition(s): recurrent colon cancer; adenocarcinoma of the rectum; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Princess Margaret Hospital Purpose - Excerpt: RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have recurrent or metastatic colorectal cancer. Phase(s): Phase II Study Type: Treatment Contact(s): Canada, Ontario; Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton, Ontario, L8V 5C2, Canada; Recruiting; Pierre Major 416-821-7610; Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, N6A 4L6, Canada; Recruiting; Mark D. Vincent 519-685-8640; Princess Margaret Hospital, Toronto, Ontario, M5G 2M9, Canada; Recruiting; Amit M. Oza 416-946-2818. Study chairs or principal investigators: Amit M. Oza, Study Chair; Princess Margaret Hospital Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00032110;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer Condition(s): adenocarcinoma of the rectum; stage III colon cancer; stage III rectal cancer; adenocarcinoma of the colon
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Study Status: This study is currently recruiting patients. Sponsor(s): Rhone Poulenc Rorer S.A. Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have undergone surgery for stage III colorectal cancer. Phase(s): Phase III Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00026273;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer Condition(s): stage III colon cancer; stage II colon cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); National Surgical Adjuvant Breast and Bowel Project Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for colon cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without oxaliplatin in treating patients who have stage II or stage III colon cancer. Phase(s): Phase III Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00004931;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Fluorouracil, Phenylbutyrate, and Indomethacin in Treating Patients With Advanced Colorectal Cancer Condition(s): recurrent colon cancer; stage IV rectal cancer; adenocarcinoma of the rectum; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Mount Sinai Medical Center Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of fluorouracil and phenylbutyrate in treating patients with stage IV colorectal cancer. Phase(s): Phase I; Phase II Study Type: Treatment Contact(s): New York; Mount Sinai Medical Center, NY, New York, New York, 10029, United States; Recruiting; Max W. Sung 212-241-7902. Study chairs or principal investigators: Max W. Sung, Study Chair; Mount Sinai Medical Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002796;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Gene Testing in Patients With Colon Cancer Condition(s): stage III colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Cancer and Leukemia Group B Purpose - Excerpt: RATIONALE: Analyzing the structure of genes found in a person's cancer cells may help doctors improve methods of treating patients with colon cancer. PURPOSE: Clinical trial to study the genes of patients treated with chemotherapy for colon cancer. Study Type: Genetic Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00003571;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Gene Therapy in Patients With Colon Cancer That Has Spread to the Liver Condition(s): recurrent colon cancer; liver metastases; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Memorial Sloan-Kettering Cancer Center Purpose - Excerpt: RATIONALE: Gene therapy may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the safety of NV1020 in patients who have colon cancer that has spread to the liver and has not responded to previous chemotherapy. Phase(s): Phase I Study Type: Treatment Contact(s): New York; Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting; Yuman Fong 212-6392016. Study chairs or principal investigators: Yuman Fong, Study Chair; Memorial Sloan-Kettering Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00012155;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Genetic Study in Patients With Stage II or Stage III Colon Cancer Condition(s): stage III colon cancer; stage II colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); NCIC-Clinical Trials Group; North Central Cancer Treatment Group Purpose - Excerpt: RATIONALE: Genetic studies may help in understanding the genetic processes that cause some types of cancer. PURPOSE: Genetic trial to study certain genes of patients who have stage II or stage III colon cancer. Study Type: Genetic Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00003833;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Genetic Study of Young Patients With Colorectal Cancer Condition(s): adenocarcinoma of the rectum; stage I rectal cancer; stage I colon cancer; stage III colon cancer; stage III rectal cancer; stage II colon cancer; stage II rectal cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); American College of Surgeons Purpose - Excerpt: RATIONALE: Identifying gene mutations may allow doctors to plan effective treatment for patients who develop colorectal cancer at an early age. PURPOSE: Genetic trial to study the significance of gene mutations in helping predict the outcome of treatment in patients who develop stage I , stage II, or stage III colorectal cancer at an early age. Study Type: Genetic Contact(s): New York; Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting; Robert J. Downey 212639-8124. Study chairs or principal investigators: Jose G. Guillem, Study Chair; American College of Surgeons Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00044967;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Hepatic Arterial Infusion Plus Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver Condition(s): adenocarcinoma of the rectum; liver metastases; stage IV rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); National Surgical Adjuvant Breast and Bowel Project; North Central Cancer Treatment Group Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations and different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of hepatic arterial infusion plus chemotherapy in treating patients who have colorectal cancer metastatic to the liver. Phase(s): Phase II Study Type: Treatment Contact(s): see Web site below
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Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00026234;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer Condition(s): mucinous adenocarcinoma of the colon; stage III colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): EORTC Gastrointestinal Tract Cancer Cooperative Group Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective for colon cancer. PURPOSE: Randomized phase III trial to study the effectiveness of high-dose fluorouracil with or without leucovorin compared with standard-dose fluorouracil plus leucovorin following surgery in treating patients who have stage III colon cancer. Phase(s): Phase III Study Type: Treatment Contact(s): Netherlands; Saint Laurentius Ziekenhuis, Roermond, 6043 CV, Netherlands; Recruiting; Jacques A. Wils 475--38-2466. Study chairs or principal investigators: Jacques A. Wils, Study Chair; EORTC Gastrointestinal Tract Cancer Cooperative Group Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00004150;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Immunotherapy After Surgery in Treating Patients With Breast Cancer, Colon Cancer, or Melanoma Condition(s): stage II melanoma; recurrent colon cancer; stage II breast cancer; stage I colon cancer; recurrent melanoma; stage III colon cancer; stage I melanoma; recurrent breast cancer; stage III melanoma; stage I breast cancer; stage IIIA breast cancer; stage II colon cancer Study Status: This study is currently recruiting patients. Sponsor(s): Centro Oncologico de Excelencia Purpose - Excerpt: RATIONALE: Immunotherapy uses different ways to stimulate the immune system and stop cancer cells from growing. Immunotherapy biological extracts may be useful as adjuvant therapy in
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treating patients who have had surgery for breast cancer, colon cancer, or melanoma. PURPOSE: Phase III trial to study the effectiveness of Corynebacterium granulosum extract as maintenance immunotherapy following surgery in treating patients with breast cancer, colon cancer, or melanoma. Phase(s): Phase III Study Type: Treatment Contact(s): Argentina, Buenos Aires; Centro Oncologico de Excelencia, Gonnet, Buenos Aires, 1987 MB, Argentina; Recruiting; Hugo Omar De Carli 021-84-3119. Study chairs or principal investigators: Hugo Omar De Carli, Study Chair; Centro Oncologico de Excelencia Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002455;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer Condition(s): recurrent colon cancer; adenocarcinoma of the rectum; stage III colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Southwest Oncology Group; Eastern Cooperative Oncology Group; North Central Cancer Treatment Group Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with that of combination chemotherapy in treating patients who have advanced colorectal cancer that has not responded to previous treatment. Phase(s): Phase III Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00005036;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Irinotecan or Fluorouracil Plus Leucovorin in Treating Patients With Previously Treated Metastatic Colorectal Cancer Condition(s): recurrent colon cancer; adenocarcinoma of the rectum; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); North Central Cancer Treatment Group Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells. PURPOSE: Phase II trial to compare the effectiveness of either irinotecan or fluorouracil plus leucovorin in treating patients who have metastatic colorectal cancer that has been previously treated with oxaliplatin with or without irinotecan. Phase(s): Phase II Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00016952;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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J-107088 in Treating Patients With Metastatic Colorectal Cancer Condition(s): recurrent colon cancer; adenocarcinoma of the rectum; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): Pharmaceutical Research Associates Inc. Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of J-107088 in treating patients who have metastatic colorectal cancer. Phase(s): Phase II Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00032071;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer Condition(s): stage III colon cancer; stage I colon cancer; adenocarcinoma of the colon; stage II colon cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Southwest Oncology Group; Eastern Cooperative Oncology Group; Radiation Therapy Oncology Group; Cancer and Leukemia Group B; NCIC-Clinical Trials Group; National Surgical Adjuvant Breast and Bowel Project; North Central Cancer Treatment Group Purpose - Excerpt: RATIONALE: Less invasive types of surgery may help reduce the number of side effects and improve recovery. It is not yet known which type of surgery is more effective for colon cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of laparoscopic-assisted colectomy with open colectomy in treating patients who have colon cancer. Phase(s): Phase III Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002575;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer Condition(s): pancreatic cancer; gastric cancer; esophageal cancer; colorectal cancer; colon cancer; rectal cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); University of Freiburg Purpose - Excerpt: RATIONALE: LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for advanced pancreatic, esophageal, stomach, colon or rectal cancer. PURPOSE: Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced pancreatic, esophageal, stomach, colon, or rectal cancer. Phase(s): Phase I Study Type: Treatment
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Contact(s): Germany; University of Freiburg Medical Center, Freiburg, D79106, Germany; Recruiting; Peter Hafkmeyer 011-49-761-2703401. Study chairs or principal investigators: Peter Hafkmeyer, Study Chair; University of Freiburg Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00010270;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer Condition(s): adenocarcinoma of the rectum; stage III colon cancer; stage III rectal cancer; stage IV rectal cancer; stage II colon cancer; stage II rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): Onyvax Purpose - Excerpt: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines made from cancer cells may make the body build an immune response to kill colorectal tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy and/or vaccine therapy in treating patients who have locally advanced or metastatic colorectal cancer. Phase(s): Phase I; Phase II Study Type: Treatment Contact(s): United Kingdom, England; St. George's Hospital, London, England, SW17 0QT, United Kingdom; Recruiting; Fiona Lofts 020-87250231. Study chairs or principal investigators: Fiona Lofts, Study Chair; Onyvax Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00007826;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Monoclonal Antibody Therapy Compared With No Further Therapy After Surgery in Treating Patients With Stage II Colon Cancer Condition(s): stage II colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Southwest Oncology Group; Eastern Cooperative Oncology Group; North Central Cancer Treatment
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Group; EORTC Gastrointestinal Tract Cancer Cooperative Group; NCICClinical Trials Group; Cancer and Leukemia Group B Purpose - Excerpt: RATIONALE: Monoclonal antibodies such as edrecolomab can locate tumor cells and either kill them or deliver tumorkilling substances to them without harming normal cells. It is not yet known whether surgery to remove colon cancer is more effect with or without monoclonal antibody therapy. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without monoclonal antibody therapy in treating patients who have stage II colon cancer. Phase(s): Phase III Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002968;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer Condition(s): recurrent colon cancer; adenocarcinoma of the rectum; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): NewBiotics Incorporated Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of NB1011 in treating patients who have metastatic or recurrent colorectal cancer that has not responded to previous treatment. Phase(s): Phase I; Phase II Study Type: Treatment Contact(s): California; Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States; Recruiting; Mark D. Pegram 310-206-8221; USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033-0804, United States; Recruiting; Heinz-Josef Lenz 323-865-3955. Study chairs or principal investigators: Mark D. Pegram, Study Chair; NewBiotics Incorporated Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00031616;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Oxaliplatin in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer Condition(s): recurrent colon cancer; adenocarcinoma of the rectum; stage III colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Roswell Park Cancer Institute Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Clinical trial to study the effectiveness of oxaliplatin in treating patients who have locally advanced or metastatic colorectal cancer that has been previously treated. Study Type: Treatment Contact(s): New York; Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States; Recruiting; Milind Javle 716-845-7614. Study chairs or principal investigators: Milind Javle, Study Chair; Roswell Park Cancer Institute Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00040820;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Colorectal Cancer Condition(s): recurrent colon cancer; adenocarcinoma of the rectum; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); UAB Comprehensive Cancer Center Purpose - Excerpt: RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Radiolabeled monoclonal antibody therapy may be effective treatment for colorectal cancer. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have recurrent or persistent colorectal cancer. Phase(s): Phase I
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Study Type: Treatment Contact(s): Alabama; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35294-3300, United States; Recruiting; Ruby F. Meredith 205-934-2763. Study chairs or principal investigators: Ruby F. Meredith, Study Chair; UAB Comprehensive Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00023933;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid in Treating Patients With Metastatic Colorectal Cancer Condition(s): adenocarcinoma of the rectum; stage IV rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Comprehensive Cancer Center
Institute
(NCI);
Herbert
Irving
Purpose - Excerpt: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Tetanus toxoid may make tumor cells more sensitive to chemotherapy and vaccine therapy. PURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy and vaccine therapy with or without tetanus toxoid in treating patients who have metastatic colorectal cancer. Phase(s): Phase II Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00027833;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Vaccine Therapy in Gastrointestinal Tract
Treating
Patients
With
Cancer
of
the
Condition(s): pancreatic cancer; gastric cancer; esophageal cancer; colorectal cancer; colon cancer; rectal cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); University of Texas
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Purpose - Excerpt: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of two different vaccines in treating patients who have cancer of the gastrointestinal tract. Phase(s): Phase II Study Type: Treatment Contact(s): Texas; University of Texas Medical Branch, Galveston, Texas, 77555-0209, United States; Recruiting; Robert P. Whitehead 409-772-1164. Study chairs or principal investigators: Robert P. Whitehead, Study Chair; University of Texas Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00012246;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Vaccine Therapy in Treating Patients With Stage II or Stage III Colon Cancer That has Been Removed During Surgery Condition(s): stage III colon cancer; stage II colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): Intracel Purpose - Excerpt: RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy combined with leucovorin and fluorouracil in treating patients who have undergone surgery to completely remove stage II or stage III colon cancer. Phase(s): Phase I; Phase II Study Type: Treatment Contact(s): District of Columbia; Washington Hospital Center, Washington, District of Columbia, 20010, United States; Recruiting; Lee E. Smith 202-877-8484; Pennsylvania; Lehigh Valley Hospital, Allentown, Pennsylvania, 18103, United States; Recruiting; Linda L. Lapos 610-4021095; Virginia; Inova Fairfax Hospital, Fairfax, Virginia, 22031, United States; Recruiting; Thomas Patrick Wright 703-560-7788. Study chairs or principal investigators: Michael G Hanna Jr., Study Chair; Intracel
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Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00016133;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer Condition(s): recurrent colon cancer; stage III colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI) Purpose - Excerpt: RATIONALE: Vaccines may make the body build an immune response that will kill cancer cells. Combining vaccine therapy with interleukin-2 may be a more effective treatment for colorectal cancer. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have locally advanced or metastatic colorectal cancer. Phase(s): Phase I; Phase II Study Type: Treatment Contact(s): Maryland; Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, 20892-1182, United States; Recruiting; Patient Recruitment 1-888-NCI-1937; Tennessee; VanderbiltIngram Cancer Center, Nashville, Tennessee, 37232-6838, United States; Recruiting; David P. Carbone 615-936-3524. Study chairs or principal investigators: John Edward Janik, Study Chair; National Cancer Institute (NCI) Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00019591;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer Condition(s): lung cancer; pancreatic cancer; gastric cancer; salivary gland cancer; head and neck cancer; colorectal cancer; adult primary liver cancer; testicular cancer; ovarian epithelial cancer; colon cancer; thyroid cancer; rectal cancer; breast cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Fox Chase Cancer Center
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Purpose - Excerpt: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may make tumor cells more sensitive to the vaccine and may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have advanced or metastatic cancer. Phase(s): Phase I Study Type: Treatment Contact(s): Pennsylvania; Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States; Recruiting; Margaret von Mehren 215-728-3545. Study chairs or principal investigators: Margaret von Mehren, Study Chair; Fox Chase Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00028496;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
ZD 1839 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Colorectal Cancer Condition(s): recurrent colon cancer; adenocarcinoma of the rectum; unspecified adult solid tumor, protocol specific; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Stanford University Purpose - Excerpt: RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug with ZD 1839 may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of ZD 1839 and oxaliplatin combined with leucovorin and fluorouracil in treating patients who have advanced solid tumors or colorectal cancer. Phase(s): Phase I; Phase II Study Type: Treatment Contact(s): California; Stanford University Medical Center, Stanford, California, 94305-5408, United States; Recruiting; Branimir Ivan Sikic 650725-8233. Study chairs or principal investigators: Branimir Ivan Sikic, Study Chair; Stanford University
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Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00025142;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer That Has Not Responded to Chemotherapy Condition(s): recurrent colon cancer; adenocarcinoma of the rectum; stage III colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); University of Texas Purpose - Excerpt: RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of colorectal cancer. PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have locally advanced or metastatic colorectal cancer that has not responded to fluorouracil and irinotecan. Phase(s): Phase II Study Type: Treatment Contact(s): Texas; Institute for Drug Development, San Antonio, Texas, 78229, United States; Recruiting; Amita Patnaik 210-949-5069; University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78284-7811, United States; Recruiting; Chris H. Takimoto 210-567-4777. Study chairs or principal investigators: Chris H. Takimoto, Study Chair; University of Texas Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00030524;jsessionid=45AB78 3531B044FB3F235C2A3A076210
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ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer Condition(s): recurrent colon cancer; adenocarcinoma of the rectum; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; adenocarcinoma of the colon Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Dana-Farber/Harvard Cancer Center Purpose - Excerpt: RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of the
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tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining ZD 1839 with combination chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of ZD 1839 combined with irinotecan, leucovorin, and fluorouracil in treating patients who have locally advanced, locally recurrent, or metastatic colorectal cancer. Phase(s): Phase I Study Type: Treatment Contact(s): Massachusetts; Dana-Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting; Charles S. Fuchs 617-6322225; Massachusetts General Hospital Cancer Center, Boston, Massachusetts, 02114, United States; Recruiting; Jeffrey William Clark 617-726-8743. Study chairs or principal investigators: Charles S. Fuchs, Study Chair; Dana-Farber/Harvard Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00026364;jsessionid=45AB78 3531B044FB3F235C2A3A076210 ·
Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy Condition(s): recurrent colon cancer; recurrent grade III follicular large cell lymphoma; recurrent mantle cell lymphoma; recurrent grade I follicular small cleaved cell lymphoma; recurrent prostate cancer; recurrent grade II follicular mixed cell lymphoma Study Status: This study is not yet open for patient recruitment. Sponsor(s): National Cancer Institute (NCI) Purpose - Excerpt: RATIONALE: Monoclonal antibodies such as CTLA-4 can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody CTLA-4 in treating patients who have lymphoma, colon cancer, or prostate cancer that has not responded to vaccine therapy. Phase(s): Phase II Study Type: Treatment Contact(s): John Edward Janik 301-402-2913. Study chairs or principal investigators: John Edward Janik, Study Chair; National Cancer Institute (NCI)
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Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00047164;jsessionid=45AB78 3531B044FB3F235C2A3A076210
Benefits and Risks20 What Are the Benefits of Participating in a Clinical Trial? If you are interested in a clinical trial, it is important to realize that your participation can bring many benefits to you and society at large: ·
A new treatment could be more effective than the current treatment for colon cancer. Although only half of the participants in a clinical trial receive the experimental treatment, if the new treatment is proved to be more effective and safer than the current treatment, then those patients who did not receive the new treatment during the clinical trial may be among the first to benefit from it when the study is over.
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If the treatment is effective, then it may improve health or prevent diseases or disorders.
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Clinical trial patients receive the highest quality of medical care. Experts watch them closely during the study and may continue to follow them after the study is over.
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People who take part in trials contribute to scientific discoveries that may help other people with colon cancer. In cases where certain diseases or disorders run in families, your participation may lead to better care or prevention for your family members. The Informed Consent
Once you agree to take part in a clinical trial, you will be asked to sign an “informed consent.” This document explains a clinical trial’s risks and benefits, the researcher’s expectations of you, and your rights as a patient.
This section has been adapted from ClinicalTrials.gov, a service of the National Institutes of Health: http://www.clinicaltrials.gov/ct/gui/c/a1r/info/whatis?JServSessionIdzone_ct=9jmun6f291. 20
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What Are the Risks? Clinical trials may involve risks as well as benefits. Whether or not a new treatment will work cannot be known ahead of time. There is always a chance that a new treatment may not work better than a standard treatment. There is also the possibility that it may be harmful. The treatment you receive may cause side effects that are serious enough to require medical attention.
How Is Patient Safety Protected? Clinical trials can raise fears of the unknown. Understanding the safeguards that protect patients can ease some of these fears. Before a clinical trial begins, researchers must get approval from their hospital’s Institutional Review Board (IRB), an advisory group that makes sure a clinical trial is designed to protect patient safety. During a clinical trial, doctors will closely watch you to see if the treatment is working and if you are experiencing any side effects. All the results are carefully recorded and reviewed. In many cases, experts from the Data and Safety Monitoring Committee carefully monitor each clinical trial and can recommend that a study be stopped at any time. You will only be asked to take part in a clinical trial as a volunteer giving informed consent.
What Are a Patient’s Rights in a Clinical Trial? If you are eligible for a clinical trial, you will be given information to help you decide whether or not you want to participate. As a patient, you have the right to: ·
Information on all known risks and benefits of the treatments in the study.
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Know how the researchers plan to carry out the study, for how long, and where.
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Know what is expected of you.
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Know any costs involved for you or your insurance provider.
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Know before any of your medical or personal information is shared with other researchers involved in the clinical trial.
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Talk openly with doctors and ask any questions.
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After you join a clinical trial, you have the right to: ·
Leave the study at any time. Participation is strictly voluntary. However, you should not enroll if you do not plan to complete the study.
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Receive any new information about the new treatment.
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Continue to ask questions and get answers.
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Maintain your privacy. Your name will not appear in any reports based on the study.
·
Know whether you participated in the treatment group or the control group (once the study has been completed). What Should You Ask before Deciding to Join a Clinical Trial?
Questions you should ask when thinking about joining a clinical trial include the following: ·
What is the purpose of the clinical trial?
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What are the standard treatments for colon cancer? Why do researchers think the new treatment may be better? What is likely to happen to me with or without the new treatment?
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What tests and treatments will I need? Will I need surgery? Medication? Hospitalization?
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How long will the treatment last? How often will I have to come back for follow-up exams?
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What are the treatment’s possible benefits to my condition? What are the short- and long-term risks? What are the possible side effects?
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Will the treatment be uncomfortable? Will it make me feel sick? If so, for how long?
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How will my health be monitored?
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Where will I need to go for the clinical trial? How will I get there?
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How much will it cost to be in the study? What costs are covered by the study? How much will my health insurance cover?
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Will I be able to see my own doctor? Who will be in charge of my care?
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Will taking part in the study affect my daily life? Do I have time to participate?
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·
How do I feel about taking part in a clinical trial? Are there family members or friends who may benefit from my contributions to new medical knowledge?
Clinical Trials and Insurance Coverage21 As you consider enrolling in a clinical trial, you will face the critical issue of how to cover the costs of care. Even if you have health insurance, your coverage may not include some or all of the patient care costs associated with a clinical trial. This is because some health plans define clinical trials as “experimental” or “investigational” procedures. Because lack of coverage for these costs can keep people from enrolling in trials, the National Cancer Institute is working with major health plans and managed care groups to find solutions. In the meantime, there are strategies that may help you deal with cost and coverage barriers. This section answers frequently asked questions about insurance coverage for clinical trial participation and directs you to additional information resources. The material here is mainly concerned with treatment clinical trials, since other types of trials (prevention, screening, etc.) are newer and generally not covered by health insurance at all. However, this guide may become more relevant for prevention and other types of trials as these trials grow more common. If you do not have any health insurance, you may find this section helpful for understanding some of the costs that trials involve.
What Costs Do Trials Involve? Who Is Usually Responsible for Paying Them? There are two types of costs associated with a trial: patient care costs and research costs. Patient care costs fall into two categories: ·
Usual care costs, such as doctor visits, hospital stays, clinical laboratory tests, x-rays, etc., which occur whether you are participating in a trial or
Adapted from the NCI: http://www.cancer.gov/clinical_trials/doc_header.aspx?viewid=1d92be79-8748-4bda-80052a56d332463b.
21
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receiving standard treatment. These costs have usually been covered by a third-party health plan, such as Medicare or private insurance. ·
Extra care costs associated with clinical trial participation, such as the additional tests that may or may not be fully covered by the clinical trial sponsor and/or research institution.
The sponsor and the participant’s health plan need to resolve coverage of these costs for particular trials. Research costs are those associated with conducting the trial, such as data collection and management, research physician and nurse time, analysis of results, and tests purely performed for research purposes. Such costs are usually covered by the sponsoring organization, such as NCI or a pharmaceutical company.
Criteria Used by Health Plans to Make Reimbursement Decisions about Trials Health insurance companies and managed care companies decide which health care services they will pay for by developing coverage policy regarding the specific services. In general, the most important factor determining whether something is covered is a health plan’s judgment as to whether the service is established or investigational. Health plans usually designate a service as established if there is a certain amount of scientific data to show that it is safe and effective. If the health plan does not think that such data exist in sufficient quantity, the plan may label the service as investigational. Health care services delivered within the setting of a clinical trial are very often categorized as investigational and not covered. This is because the health plan thinks that the major reason to perform the clinical trial is that there is not enough data to establish the safety and effectiveness of the service being studied. Thus, for some health plans, any mention of the fact that the patient is involved in a clinical trial results in a denial of payment. Your health plan may define specific criteria that a trial must meet before extending coverage, such as the following:
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Sponsorship Some plans may only cover costs of trials sponsored by organizations whose review and oversight of the trial is careful and scientifically rigorous, according to standards set by the health plan.
Trial Phase and Type Some plans may cover patient care costs only for the clinical trials they judge to be “medically necessary” on a case-by-case basis. Trial phase may also affect coverage; for example, while a plan may be willing to cover costs associated with Phase III trials, which include treatments that have already been successful with a certain number of people, the plan may require some documentation of effectiveness before covering a Phase I or II trial. While health plans are interested in efforts to improve prevention and screening, they currently seem less likely to have a review process in place for these trials. Therefore, it may be more difficult to get coverage for the care costs associated with them. Some plans, especially smaller ones, will not cover any costs associated with a clinical trial. Policies vary widely, but in most cases your best bet is to have your doctor initiate discussions with the health plan. Cost “Neutrality” Some health plans may limit coverage to trials they consider cost-neutral (i.e., not significantly more expensive than the treatments considered standard). Lack of Standard Therapy Some plans limit coverage of trials to situations in which no standard therapy is available. Facility and Personnel Qualifications A health plan may require that the facility and medical staff meet specific qualifications to conduct a trial involving unique services, especially
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intensive therapy such as a bone marrow transplant chemotherapy with bone marrow/ stem cell rescue).
(high-dose
Clinical Trials and Medicare Coverage For up-to-date information about Medicare coverage of clinical trials, go to the Web site for the Centers for Medicaid & Medicare (http://www.hcfa.gov/coverage/8d.htm; formerly the Health Care Financing Administration). As of January 2001, the following information was accurate22: What Will Medicare Pay? ·
Anything normally covered is still covered when it is part of a clinical trial. This includes test, procedures, and doctor visits that are ordinarily covered.
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Anything normally covered even if it is a service or item associated with the experimental treatment. For example, Medicare will pay for the intravenous administration of a new chemotherapy drug being tested in a trial, including any therapy to prevent side effects from the new drug.
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Anything normally covered even if it resulted from your being in the clinical trial. For example, a test or hospitalization resulting from a side effect of the new treatment that Medicare would ordinarily cover. What Costs Are Not Covered?
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Investigational items or services being tested in a trial. Sponsors of clinical trials often provide the new drug free, but make sure you ask your doctor before you begin.
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Items or services used solely for the data collection needs of the trial.
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Anything being provided free by the sponsor of the trial.
On June 7, 2000, Present Clinton announced that Medicare would revise its payment policy to reimburse the routine patient care costs of clinical trials. The announcement is available for public viewing at the following Web address: http://www.cancer.gov/clinical_trials/doc.aspx?viewid=320DD013-BA7A-4177-A0002011089F34A0.
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What Kinds of Clinical Trials Are Covered? NCI’s Cancer Information Service has provided a fact sheet for Medicare beneficiaries at the following Web site: http://cis.nci.nih.gov/fact/8_14.htm. In general, cancer treatment and diagnosis trials are covered if: ·
They are funded by the National Cancer Institute (NCI), NCI-Designated Cancer Centers, NCI-Sponsored Clinical Trials Cooperative Groups and all other Federal agencies that fund cancer research. Other trials may be eligible for coverage and doctors can ask Medicare to pay the patients’ costs. Ask your doctor about this before you begin.
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They are designed to treat or diagnose your cancer.
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The purpose or subject of the trial is within a Medicare benefit category. For example, cancer diagnosis and treatment are Medicare benefits, so these trials are covered. Cancer prevention trials are not currently covered.
Increasing the Likelihood of Insurance Coverage for Trials23 There are several steps you can follow to deal with coverage issues up front when deciding to enter a clinical trial. Along the way, enlist the help of family members and your doctor or other health professionals. You may find the following checklist useful:
Understand the Costs Associated with the Trial Ask your doctor or the trial’s contact person about the costs that must be covered by you or your health plan. Are these costs significantly higher than those associated with standard care? Also, inquire about the experience of other patients in the trial. Have their plans paid for their care? Have there been any persistent problems with coverage? How often have the trial’s administrators been successful in getting plans to cover patient care costs?
This section has been adapted from the NCI: http://www.cancer.gov/clinical_trials/doc_header.aspx?viewid=1d92be79-8748-4bda-80052a56d332463b&docid=0df4397a-eccb-465f-bd33-a89e7a708c46.
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Understand Your Health Plan Be sure you know what’s in your policy; request and carefully review the actual contract language. If there’s a specific exclusion for “experimental treatment,” look closely at the policy to see how the plan defines such treatment and under what conditions it might be covered. If it is not clearly defined, call the plan’s customer service line, consult their Web site, and/or write to them. Ask for specific information about clinical trials coverage.
Work Closely with Your Doctor Talk with your doctor about the paperwork he or she submits to your health plan. If there have been problems with coverage in the past, you might ask your doctor or the hospital to send an information package to the plan that includes studies supporting the procedure’s safety, benefits, and medical appropriateness. This package might include: ·
Publications from peer-reviewed literature about the proposed therapy that demonstrate patient benefits;
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A letter that uses the insurance contract’s own language to explain why the treatment, screening method, or preventive measure should be covered;
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Letters from researchers that explain the clinical trial;
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Support letters from patient advocacy groups.
Be sure to keep your own copy of any materials that the doctor sends to your health plan for future reference. Work Closely with Your Company’s Benefits Manager This person may be helpful in enlisting the support of your employer to request coverage by the health plan. Give Your Health Plan a Deadline Ask the hospital or cancer center to set a target date for the therapy. This will help to ensure that coverage decisions are made promptly.
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Know Your Rights24 A number of state governments are addressing the question of whether insurance companies ought to cover the costs associated with patients’ participation in clinical trials. Lack of such coverage is a significant barrier to many patients who might otherwise benefit from enrolling in a trial. Lack of coverage also makes it harder for researchers to successfully conduct trials that could improve prevention and treatment options. Information on State initiatives and legislation concerning cancer-related clinical trials is available at http://www.cancer.gov/ClinicalTrials/insurancelaws. By conducting your own research and learning about your rights, you may increase the likelihood that your insurance company will cover the costs of a trial.
If Your Insurance Claim Is Denied after the Trial Has Begun If a claim is denied, read your policy to find out what steps you can follow to make an appeal. In “What Cancer Survivors Need to Know about Health Insurance”, the National Coalition for Cancer Survivorship suggests that you and your doctor demonstrate to the health plan that: ·
The therapy is not just a research study, but also a valid procedure that benefits patients;
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Your situation is similar to that of other patients who are participating in clinical trials as part of a covered benefit;
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Possible complications have been anticipated and can be handled effectively.
You also may wish to contact your state insurance counseling hotline or insurance department for more help, or write your state insurance commissioner describing the problem. Where Else Can I Turn for Assistance? It’s never easy to deal with financial issues when you or a loved one faces cancer. Unfortunately, costs can present a significant barrier to clinical trials participation. The range of insurance issues and health plan contracts makes it impossible to deal with all of them here. You may wish to consult this partial list of publications, organizations, and Web sites for more information: 24
Adapted from Cancer.gov: http://www.cancer.gov/ClinicalTrials/insurancelaws.
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Publications What Cancer Survivors Need to Know about Health Insurance National Coalition of Cancer Survivorship 1010 Wayne Avenue, 5th floor Silver Spring, MD 20910 (301) 650-8868 http://www.cansearch.org/ Cancer Treatments Your Insurance Should Cover The Association of Community Cancer Centers 11600 Nebel Street, Suite 201 Rockville, MD 20852 (301) 984-9496 http://www.accc-cancer.org/main2001.shtml The Managed Care Answer Guide Patient Advocate Foundation 739 Thimble Shoals Boulevard, Suite 704 Newport News, VA 23606 (757) 873-6668 E-mail:
[email protected] 1998 Guide to Health Insurance for People with Medicare, The Medicare Handbook Medicare Helpline: 1-800-444-4606 Health Care Financing Administration: http://www.hcfa.gov/ New Medicare site: http://www.medicare.gov/ Assistance Programs Candlelighters Childhood Cancer Foundation Ombudsman Program 910 Woodmont Avenue, #4607 Bethesda, MD 20814 (301) 657-8401; 1-800-366-2223 (toll-free) E-mail:
[email protected] http://www.candlelighters.org The Ombudsman Program helps families of children with cancer and survivors of childhood cancer resolve a range of problems, including insurance coverage difficulties. Local groups appoint a Parent Advocate who works with the treatment center on behalf of families.
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Medical Care Management Corporation 5272 River Road, Suite 650 Bethesda, MD 20816-1405 (301) 652-1818 email:
[email protected] http://www.mcman.com/ Working for a range of clients, including health plans, employers, and patients, MCMC conducts independent, objective reviews of hightechnology medical care cases to assist in decision-making. While it does charge for its services, MCMC also offers a volunteer program for those who cannot afford to pay. More Information Resources OncoLink A service of the University of Pennsylvania Cancer Center. http://www.oncolink.com/ In addition to general cancer information, this web site features a section on financial information for patients. Among the topics: viatical settlements, life insurance, a glossary of financial and medical terms, and news about billing and insurance. American Association of Health Plans 1129 20th Street, NW, Suite 600 Washington, DC 20036-3421 (202) 778-3200 http://www.aahp.org/ The Web site section “For Consumers” includes a fact sheet on clinical research that describes various health plans’ efforts to support research initiatives and collaborate with academic health centers and universities. Health Insurance Association of America 555 13th Street, NW Washington, DC 20004 (202) 824-1600 ·
Home page: http://www.hiaa.org/
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Consumer Information: http://www.hiaa.org/consumer/
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Insurance Counseling Hotlines by State: http://www.hiaa.org/consumer/insurance_counsel.cfm
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State Insurance Departments: http://www.hiaa.org/consumer/state_insurance.cfm
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Government Initiatives to Expand Insurance Coverage for Trials25 The good news is that there has been a recent effort in the U.S. to assure clinical trials coverage, with NCI involved in several new initiatives as described below: NCI-Department of Defense Agreement An innovative 1996 agreement between NCI and the Department of Defense (DoD) has given thousands of DoD cancer patients more options for care and greater access to state-of-the-art treatments. Patients who are beneficiaries of TRICARE/CHAMPUS, the DoD’s health program, are covered for NCIsponsored Phase II and Phase III clinical treatment trials. NCI and DoD are refining a system that allows physicians and patients to determine quickly what current trials meet their needs and where they are taking place. NCI-Department of Veterans Affairs Agreement A 1997 agreement with the Department of Veterans Affairs provides coverage for eligible veterans of the armed services to participate in NCIsponsored prevention, diagnosis, and treatment studies nationwide. For additional information, see the VA/DoD Beneficiaries Digest Page at http://www.va.gov/cancer.htm.
Midwest Health Plans Agreement Some NCI Cooperative Groups have reached agreements with several insurers in Wisconsin and Minnesota to provide more than 200,000 people with coverage. This coverage is allocated for patient care costs if they participate in a cooperative group-sponsored trial.
Adapted from the NCI: http://www.cancer.gov/clinical_trials/doc_header.aspx?viewid=1d92be79-8748-4bda-80052a56d332463b&docid=d8092601-daf9-4794-8536-3be2712eb6b9.
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Pediatric Cancer Care Network This network, a cooperative agreement among the Children’s Cancer Group, the Pediatric Oncology Group, and the Blue Cross Blue Shield System Association (BCBS) nationwide, will ensure that children of BCBS subscribers receive care at designated centers of cancer care excellence and may promote the enrollment of children in Cooperative Group clinical trials.
Keeping Current on Clinical Trials Various government agencies maintain databases on trials. The U.S. National Institutes of Health, through the National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and physicians with current information about clinical research across the broadest number of diseases and conditions. The site was launched in February 2000 and currently contains approximately 5,700 clinical studies in over 59,000 locations worldwide, with most studies being conducted in the United States. ClinicalTrials.gov receives about 2 million hits per month and hosts approximately 5,400 visitors daily. To access this database, simply go to their Web site (www.clinicaltrials.gov) and search by “colon cancer” (or synonyms). While ClinicalTrials.gov is the most comprehensive listing of NIH-supported clinical trials available, not all trials are in the database. The database is updated regularly, so clinical trials are continually being added. The following is a list of specialty databases affiliated with the National Institutes of Health that offer additional information on trials: ·
For clinical studies at the Warren Grant Magnuson Clinical Center located in Bethesda, Maryland, visit their Web site: http://clinicalstudies.info.nih.gov/
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For clinical studies conducted at the Bayview Campus in Baltimore, Maryland, visit their Web site: http://www.jhbmc.jhu.edu/studies/index.html
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For cancer trials, visit the National Cancer Institute: http://cancertrials.nci.nih.gov/
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General References The following references describe clinical trials and experimental medical research. They have been selected to ensure that they are likely to be available from your local or online bookseller or university medical library. These references are usually written for healthcare professionals, so you may consider consulting with a librarian or bookseller who might recommend a particular reference. The following includes some of the most readily available references (sorted alphabetically by title; hyperlinks provide rankings, information and reviews at Amazon.com): ·
A Guide to Patient Recruitment : Today’s Best Practices & Proven Strategies by Diana L. Anderson; Paperback - 350 pages (2001), CenterWatch, Inc.; ISBN: 1930624115; http://www.amazon.com/exec/obidos/ASIN/1930624115/icongroupinterna
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A Step-By-Step Guide to Clinical Trials by Marilyn Mulay, R.N., M.S., OCN; Spiral-bound - 143 pages Spiral edition (2001), Jones & Bartlett Pub; ISBN: 0763715697; http://www.amazon.com/exec/obidos/ASIN/0763715697/icongroupinterna
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The CenterWatch Directory of Drugs in Clinical Trials by CenterWatch; Paperback - 656 pages (2000), CenterWatch, Inc.; ISBN: 0967302935; http://www.amazon.com/exec/obidos/ASIN/0967302935/icongroupinterna
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The Complete Guide to Informed Consent in Clinical Trials by Terry Hartnett (Editor); Paperback - 164 pages (2000), PharmSource Information Services, Inc.; ISBN: 0970153309; http://www.amazon.com/exec/obidos/ASIN/0970153309/icongroupinterna
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Dictionary for Clinical Trials by Simon Day; Paperback - 228 pages (1999), John Wiley & Sons; ISBN: 0471985961; http://www.amazon.com/exec/obidos/ASIN/0471985961/icongroupinterna
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Extending Medicare Reimbursement in Clinical Trials by Institute of Medicine Staff (Editor), et al; Paperback 1st edition (2000), National Academy Press; ISBN: 0309068886; http://www.amazon.com/exec/obidos/ASIN/0309068886/icongroupinterna
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Handbook of Clinical Trials by Marcus Flather (Editor); Paperback (2001), Remedica Pub Ltd; ISBN: 1901346293; http://www.amazon.com/exec/obidos/ASIN/1901346293/icongroupinterna
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Vocabulary Builder The following vocabulary builder gives definitions of words used in this chapter that have not been defined in previous chapters: Adenocarcinoma: Cancer that begins in cells that line certain internal organs and that have glandular (secretory) properties. [NIH] Antibody: A type of protein made by certain white blood cells in response to a foreign substance (antigen). Each antibody can bind to only a specific antigen. The purpose of this binding is to help destroy the antigen. Antibodies can work in several ways, depending on the nature of the antigen. Some antibodies destroy antigens directly. Others make it easier for white blood cells to destroy the antigen. [NIH] Antineoplastons: Substances isolated from normal human blood and urine being tested as a type of treatment for some tumors and AIDS. [NIH] Arterial: Pertaining to an artery or to the arteries. [EU] Bevacizumab: A monoclonal antibody that may prevent the growth of blood vessels from surrounding tissue to a solid tumor. [NIH] Capecitabine: An anticancer drug that belongs to the family of drugs called antimetabolites. [NIH] Carboplatin: An anticancer drug that belongs to the family of drugs called platinum compounds. [NIH] Chemoembolization: A procedure in which the blood supply to the tumor is blocked surgically or mechanically, and anticancer drugs are administered directly into the tumor. This permits a higher concentration of drug to be in contact with the tumor for a longer period of time. [NIH] Chronotherapy: The adaptation of the administration of drugs to circadian rhythms. The concept is based on the response of biological functions to time-related events, such as the low point in epinephrine levels between 10 p.m. and 4 a.m. or the elevated histamine levels between midnight and 4 a.m. The treatment is aimed at supporting normal rhythms or modifying therapy based on known variations in body rhythms. While chronotherapy is commonly used in cancer chemotherapy, it is not restricted to cancer therapy or to chemotherapy. [NIH] Corynebacterium: A genus of asporogenous bacteria that is widely distributed in nature. Its organisms appear as straight to slightly curved rods and are known to be human and animal parasites and pathogens. [NIH] Cryosurgery: Treatment performed with an instrument that freezes and destroys abnormal tissues. This procedure is a form of cryotherapy. [NIH]
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Curcumin: A dye obtained from tumeric, the powdered root of Curcuma longa Linn. It is used in the preparation of curcuma paper and the detection of boron. Curcumin appears to possess a spectrum of pharmacological properties, due primarily to its inhibitory effects on metabolic enzymes. [NIH] Dexamethasone: A synthetic steroid (similar to steroid hormones produced naturally in the adrenal gland). Dexamethasone is used to treat leukemia and lymphoma and may be used to treat some of the problems caused by other cancers and their treatment. [NIH] Edrecolomab: A type of monoclonal antibody used in cancer detection or therapy. Monoclonal antibodies are laboratory-produced substances that can locate and bind to cancer cells. [NIH] Epithelial: Refers to the cells that line the internal and external surfaces of the body. [NIH] Esophageal: Having to do with the esophagus, the muscular tube through which food passes from the throat to the stomach. [NIH] Floxuridine: An anticancer drug that belongs to the family of drugs called antimetabolites. [NIH] Fluorouracil: An anticancer drug that belongs to the family of drugs called antimetabolites. [NIH] Gastric: Having to do with the stomach. [NIH] Grade: The grade of a tumor depends on how abnormal the cancer cells look under a microscope and how quickly the tumor is likely to grow and spread. Grading systems are different for each type of cancer. [NIH] Immunotoxin: An antibody linked to a toxic substance. Some immmunotoxins can bind to cancer cells and kill them. [NIH] Indomethacin: A drug that belongs to the family of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Indomethacin reduces pain, fever, swelling and redness. It is also being used to reduce tumorinduced suppression of the immune system and to increase the effectiveness of anticancer drugs. [NIH] Infusion: A method of putting fluids, including drugs, into the bloodstream. Also called intravenous infusion. [NIH] Intrahepatic: Within the liver. [NIH] Intravenous: IV. Into a vein. [NIH] Invasive: 1. having the quality of invasiveness. 2. involving puncture or incision of the skin or insertion of an instrument or foreign material into the body; said of diagnostic techniques. [EU] Irinotecan: An anticancer drug that belongs to a family of anticancer drugs called topoisomerase inhibitors. It is a camptothecin analogue. Also called
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CPT 11. [NIH] Leucovorin: A drug used to protect normal cells from high doses of the anticancer drug methotrexate. It is also used to increase the antitumor effects of fluorouracil and tegafur-uracil, an oral treatment alternative to intravenous fluorouracil. [NIH] Metastatic: Having to do with metastasis, which is the spread of cancer from one part of the body to another. [NIH] Mucinous: Containing or resembling mucin, the main compound in mucus. [NIH]
Oxaliplatin: An anticancer drug that belongs to the family of drugs called platinum compounds. [NIH] Phenylbutyrate: An anticancer drug that belongs to the family of drugs called differentiating agents. [NIH] Radiolabeled: Any compound that has been joined with a radioactive substance. [NIH] Randomized: Describes an experiment or clinical trial in which animal or human subjects are assigned by chance to separate groups that compare different treatments. [NIH] Regimen: A treatment plan that specifies the dosage, the schedule, and the duration of treatment. [NIH] Sargramostim: A colony-stimulating factor that stimulates the production of blood cells, especially platelets, during chemotherapy. It is a cytokine that belongs to the family of drugs called hematopoietic (blood-forming) agents. Also called GM-CSF. [NIH] Testicular: Pertaining to a testis. [EU] Tetanus: A disease caused by tetanospasmin, a powerful protein toxin produced by clostridium tetani. Tetanus usually occurs after an acute injury, such as a puncture wound or laceration. Generalized tetanus, the most common form, is characterized by tetanic muscular contractions and hyperreflexia. Localized tetanus presents itself as a mild condition with manifestations restricted to muscles near the wound. It may progress to the generalized form. [NIH] Trastuzumab: A type of monoclonal antibody used in cancer detection or therapy. Monoclonal antibodies are laboratory-produced substances that can locate and bind to cancer cells. Trastuzumab blocks the effects of the growth factor protein HER2, which transmits growth signals to breast cancer cells. [NIH]
Unresectable: Unable to be surgically removed. [NIH] Urine: Fluid containing water and waste products. Urine is made by the kidneys, stored in the bladder, and leaves the body through the urethra. [NIH]
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Vaccine: A substance or group of substances meant to cause the immune system to respond to a tumor or to microorganisms, such as bacteria or viruses. [NIH]
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PART II: ADDITIONAL RESOURCES AND ADVANCED MATERIAL
ABOUT PART II In Part II, we introduce you to additional resources and advanced research on colon cancer. All too often, patients who conduct their own research are overwhelmed by the difficulty in finding and organizing information. The purpose of the following chapters is to provide you an organized and structured format to help you find additional information resources on colon cancer. In Part II, as in Part I, our objective is not to interpret the latest advances on colon cancer or render an opinion. Rather, our goal is to give you access to original research and to increase your awareness of sources you may not have already considered. In this way, you will come across the advanced materials often referred to in pamphlets, books, or other general works. Once again, some of this material is technical in nature, so consultation with a professional familiar with colon cancer is suggested.
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CHAPTER 4. STUDIES ON COLON CANCER Overview Every year, academic studies are published on colon cancer or related conditions. Broadly speaking, there are two types of studies. The first are peer reviewed. Generally, the content of these studies has been reviewed by scientists or physicians. Peer-reviewed studies are typically published in scientific journals and are usually available at medical libraries. The second type of studies is non-peer reviewed. These works include summary articles that do not use or report scientific results. These often appear in the popular press, newsletters, or similar periodicals. In this chapter, we will show you how to locate peer-reviewed references and studies on colon cancer. We will begin by discussing research that has been summarized and is free to view by the public via the Internet. We then show you how to generate a bibliography on colon cancer and teach you how to keep current on new studies as they are published or undertaken by the scientific community.
The Combined Health Information Database The Combined Health Information Database summarizes studies across numerous federal agencies. To limit your investigation to research studies and colon cancer, you will need to use the advanced search options. First, go to http://chid.nih.gov/index.html. From there, select the “Detailed Search” option (or go directly to that page with the following hyperlink: http://chid.nih.gov/detail/detail.html). The trick in extracting studies is found in the drop boxes at the bottom of the search page where “You may refine your search by.” Select the dates and language you prefer, and the
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format option “Journal Article.” At the top of the search form, select the number of records you would like to see (we recommend 100) and check the box to display “whole records.” We recommend that you type in “colon cancer” (or synonyms) into the “For these words:” box. Consider using the option “anywhere in record” to make your search as broad as possible. If you want to limit the search to only a particular field, such as the title of the journal, then select this option in the “Search in these fields” drop box. The following is a sample of what you can expect from this type of search: ·
Patient Experience and Preferences Toward Colon Cancer Screening: A Comparison of Virtual Colonoscopy and Conventional Colonoscopy Source: Gastrointestinal Endoscopy. 54(3):210-315, 2001. Summary: Researchers assessed patient tolerance of virtual colonoscopy (VC) compared to conventional colonoscopy (CC), characterizing patient preferences for these techniques. People referred to a Veterans Affairs Medical Center gastrointestinal clinic for colonoscopy for any indication were recruited to undergo VC prior to receiving CC. CC was performed with the patient under conscious sedation, while VC was performed without sedation. They completed a questionnaire after the VC and again after completing both tests. The questionnaire assessed overall pain, discomfort, and lack of respect. Their preferences for VC versus CC were determined using a time tradeoff technique. To verify the stability of responses, participants completed an additional questionnaire by mail at 24 hours. At both 0 and 24 hours, participants reported more pain and discomfort and less respect after VC than after CC. They preferred CC and said they would be willing to wait longer for CC as opposed to undergoing VC. Both procedures were well-tolerated overall. The researchers conclude that improvements in patient tolerance and acceptance of VC are necessary if this test is to become competitive as an alternative screening modality. 6 figures, 3 tables, 12 references.
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Virtual Colonoscopy: A New Tool for Colorectal Cancer Screening Source: Current Opinion in Gastroenterology. 17(1):78-85, January 2001. Summary: The authors conducted a literature review on virtual colonoscopy as a screening tool for colorectal cancer, including the technique, image display, image reconstruction, clinical trial results, and feasibility. The basic technique of virtual colonoscopy involves (1) cleansing the patient's colon with standard barium enema or colonoscopy bowel preparation, colonic insufflation with room air or carbon dioxide, and (3) thin-section helical computer tomography (CT) of the abdomen and pelvis followed by computer manipulation of the CT dataset. Virtual colonoscopy requires a well prepared, cleansed colon to achieve
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appropriate sensitivity and specificity. CT scan acquisition usually involves the use of both supine and prone helical CT datasets to (1) help differentiate between mobile stool and fixed pathology such as cancers or polyps; (2) allow more even distention of the colon; and (3) improve visualization of segments of the colon obscured by intraluminal fluid. CT scanning usually takes less than 20 minutes. The radiation dose required for virtual colonoscopy is about 20 percent lower than the typical dose for double-contrast barium enema. After image acquisition, the CT data can be viewed using a variety of techniques, including (1) simple evaluation of the axial CT images at lung window settings, (2) reformatted twodimensional images at cross-sectional and orthogonal planes to the long axis of the colon, (3) three-dimensional endoluminal-simulating conventional endoscopy images, and (4) extraluminal images that simulate barium enema images. Virtual endoscopy based on threedimensional magnetic resonance imaging is also feasible and may be an alternative to CT. Preliminary results show that the accuracy of virtual colonoscopy for polyp detection exceeds barium enema and approaches conventional colonoscopy. The performance of virtual colonoscopy as a screening method has not yet been established. The authors conclude that (1) results of virtual colonoscopy studies are promising; and (2) if it proves to be an accurate, reliable, and cost-effective method for detecting polyps and early cancer, then it may improve population participation in screening programs and reduce the impact of colorectal cancer. 3 figures, 36 references. ·
Colorectal Cancer Screening: New Directions, Evolving Guidelines Source: Patient Care. 35(4):24-30, 33-34, February 28, 2001. Summary: The author reviews existing guidelines, recent study data, and the controversies concerning which screening options are best for colorectal cancer detection. While all individuals age 50 years and older should undergo screening for colorectal cancer, many primary care physicians report that they do not screen all eligible patients in their practice. Several options are offered to physicians and patients regarding colorectal screening and the physician and patient together should choose an appropriate screening regimen. Screening can prevent colorectal cancer through the detection and removal of precancerous polyps. Current views place an emphasis on total colon examination with colonoscopy in average-risk persons. Annual fecal occult blood testing combined with flexible sigmoidoscopy every 5 years is the most costeffective overall screening strategy available. Barriers to screening include patient unwillingness to discuss or have this part of the anatomy examined, physician's comfort level in discussing and performing
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colorectal screening, reimbursement, the economics of doing flexible sigmoidoscopy screening in the primary care office, and insufficient capacity to perform population-wide screening colonoscopy. 1 figure, 15 references. ·
New Test May Be More Accurate in Detecting Precancerous Polyps and Curable Colorectal Cancers Source: Primary Care and Cancer. 21(3):14-16, March 2001. Summary: According to Dr. David Ahlquist, a new, noninvasive DNA test for detecting precancerous polyps and curable colorectal cancers was 91 percent sensitive for detecting cancer throughout the colon. The researchers believe that this test, although about 2 years away from becoming widely available for public use, could significantly change the way screening for colorectal cancer is done. This new test requires a stool sample and involves analyzing DNA that is shed from the surface of colorectal cancer tumors and excreted in the stool. Precancerous polyps and early-stage cancer yield specific DNA abnormalities. This new test measures these abnormalities and results in the high accuracy of detection. This test needs to undergo another phase of clinical trials. Meanwhile, Mayo Clinic physicians encourage people age 50 years and older to continue following their physician's advice and the current recommendations for screening. The researchers believe that this new DNA test may replace the fecal occult blood test that yields as many as 5 to 10 percent false-positive results. This new test also has several patientfriendly features: (1) Patients can provide stool samples at home using a special kit that fits on the toilet seat, (2) it requires no special dietary or medication restrictions, and (3) no bowel preparation is needed. This new DNA test has the potential to significantly reduce the morbidity and mortality of colorectal cancer. 1 figure, 1 reference.
·
Virtual Colonoscopy Is a Promising Technology for Colon Cancer Screening Source: Primary Care and Cancer. 21(3):12-13, March 2001. Summary: According to Dr. Richard J. Farrell, virtual colonoscopy is an accurate screening method for colorectal cancer in lesions greater than 10 millimeters. This new screening method also has good patient tolerance. Virtual colonoscopy, or computed tomography (CT) colonoscopy, uses thin-section, helical CT to generate high-resolution two-dimensional axial images and three-dimensional endoluminal images. Physicians at the Beth Israel Deaconess Hospital in Boston recruited 100 patients at high risk for colorectal cancer and polyps. All underwent virtual colonoscopy prior to elective conventional colonoscopy. Using conventional
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colonoscopy, 45 of these patients had normal findings. In the other 55 patients, the researchers found 88 polyps and 13 masses, including 9 carcinomas. Virtual colonoscopy found (1) 12 (90 percent) of the 13 masses, all of which were greater than 20 millimeters; (2) 28 (92 percent) of 31 polyps that were greater than 10 millimeters; (3) 15 (65 percent) of 23 polyps that were 6 to 9 millimeters; and (4) 12 (35 percent) of 34 polyps that were 5 millimeters or smaller. There were 11 false-positive findings of polyps and 3 false-positive findings of masses, resulting in a specificity of 90 percent. Dr. Farrell indicated that conventional colonoscopy remains the gold standard, but virtual colonoscopy is a good diagnostic tool. 1 figure. ·
Inflammatory Bowel Disease Flare, or Colon Cancer? Source: Primary Care and Cancer. 21(1):38-41, 58, January 2001. Summary: A physician discusses the risk of colorectal cancer in patients with chronic inflammatory bowel disease (IBD) and the need for a colonoscopic surveillance program throughout their lives. While the risk of colorectal cancer has long been known in ulcerative colitis patients, only recently has the colon cancer risk of Crohn's colitis been recognized as being of similar magnitude. It is unclear whether coincident colon cancer risk factors, such as a family history of colorectal neoplasm, further heighten the cancer risk in these patients. However, other contributing factors, such as the complication of primary sclerosing cholangitis, have been recognized. Colonoscopy is the screening tool of choice in IBD rather than sigmoidoscopy. Colon cancer in IBD typically follows a premalignant dysplastic phase. The likelihood of finding colon cancer at colectomy after high-grade dysplasia has been identified is about 40 percent. Symptoms of new colon cancer in individuals may be exceedingly difficult to distinguish from an exacerbation of colitis. Symptoms such as weight loss, loss of appetite, or progressive anemia should be evaluated aggressively to allow for prompt surgical resection in response to the development of dysplasia or cancer. It may be appropriate to offer prophylactic colectomy to younger ulcerative colitis patients once their colitis has been established for a decade or more, as opposed to undergoing colonoscopy every year or two for the remainder of their lives. 3 figures, 3 tables, 10 references.
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Differing Attitudes Toward Virtual and Conventional Colonoscopy for Colorectal Cancer Screening: Surveys Among Primary Care Physicians and Potential Patients Source: American Journal of Gastroenterology. 96(3):887-893, March 2001.
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Summary: Researchers examined attitudes of primary care physicians and potential screening patients toward computed tomography colonoscopy (virtual colonoscopy) and conventional colonoscopy for colorectal cancer (CRC) screening. Investigators sent questionnaires by mail or E-mail to 1,000 physicians across the United States and 400 potential patients. Both questionnaires asked respondents about their preferences for virtual and conventional colonoscopy and the reasons for their preferences. Usable responses were received from 188 physicians (response rate 18.8 percent) and 323 potential patients (response rate 80.5 percent). On the basis of information about invasiveness, 76.6 percent of potential patients and 47.3 percent of physicians initially preferred virtual colonoscopy. When information about colon cleansing was given, the proportion of physicians and potential patients preferring virtual colonoscopy fell to 40.8 and 67.9 percent, respectively. When reminded that conventional colonoscopy, but not virtual colonoscopy, allows direct visualization of the colon, the proportion of physicians favoring virtual colonoscopy decreased further to 31.0 percent; however, the proportion of patients choosing virtual colonoscopy only dropped to 64.3 percent. When told that only conventional colonoscopy allows for the therapeutic intervention of polypectomy, the proportion of physicians favoring virtual colonoscopy dropped to 25.7 percent. The proportion of patients favoring virtual colonoscopy when given this information fell markedly to 47.0 percent. When informed that virtual colonoscopy does not require sedation, the proportion of physicians and patients favoring virtual colonoscopy rose to 51.6 and 67.4 percent, respectively. Across all questions, regardless of information provided, 60.2 percent of potential patients and 44.9 percent of physicians preferred virtual colonoscopy to conventional colonoscopy. Additionally, 82.3 percent of potential patients stated that they would comply more with recommendations for CRC screening and 61.7 percent of physicians would refer more patients for screening if virtual colonoscopy was available. Researchers conclude that potential patients preferred virtual to conventional colonoscopy, whereas physicians favored conventional colonoscopy. Physicians placed more importance on the ability of conventional colonoscopy to visualize the colonic mucosa directly and the opportunity for therapy. Potential patients were more encouraged than physicians by the availability of virtual colonoscopy to improve participation in CRC screening. 2 figures, 8 tables, 19 references. ·
Colorectal Cancer: Not an Equal Opportunity Cancer (Editorial) Source: Gastroenterology. 120(4):1043-1046, March 2001.
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Summary: The author discusses racial and ethnic variations in colorectal cancer (CRC) incidence and mortality in the United States. The discussion focuses on two issues: (1) Why it is important to understand racial and ethnic variations in CRC incidence and mortality; and (2) why Americans of every race and ethnic group are not getting screened for CRC. The discussion specifically considers (1) CRC risk associated with race and ethnicity, (2) public perception and awareness of CRC, and (3) barriers to CRC screening. Rates of participation in screening are better if it is recommended by health care providers. The communication of risk of disease and benefits of screening to ethnic minorities may be especially ineffective. The process of risk communication to minorities has received little attention despite the fact that some groups suffer disproportionately from certain diseases. If there are race/ethnicity cultural barriers to colon screening, the author notes that one must study and understand these obstacles and develop appropriate educational tools. Important barriers to screening include lack of payment by insurers and lack of access to health care. The fact that a large proportion of the medically uninsured are black and fall into a higher risk group that is most likely to benefit from colon screening highlights the importance of finding a remedy for this problem. 21 references. ·
Colon Cancer in Women Source: Association of Women's Health, Obstetric and Neonatal Nurses Lifelines. 5(3):26-32, June 2001. Summary: The author provides women's health care nurses with information on basic genetic concepts, the role of genes in the development of cancer, and cancer syndromes and cancer genetic services regarding colon cancer. Colon cancer genes are dominant, meaning that a single copy can greatly increase an individual's cancer risk. All cancers are genetic in origin, but hereditary cancer results from (1) the presence of a genetic mutation in a germ cell that is reproduced in every cell of an individual's body, (2) the somatic mutation of the other gene in that pair, and (3) additional somatic mutations in the same cell line until control of cell growth and differentiation is lost. The two most common hereditary colon cancer syndromes are hereditary nonpolyposis colorectal cancer (HNPCC) and familial adenomatous polyposis (FAP). HNPCC is characterized by (1) the presence of syndrome cancers in many individuals within a family, (2) more than one primary cancer in an individual, (3) high incidence of colon cancers, (4) early age at onset, and (5) proximal location of most of the cancers. The risk for colon cancer in an HNPCC mutation carrier is 85 to 90 percent for males and as low as 54 percent for females. FAP is characterized by (1) the presence of hundreds
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to thousands of polyps in the colon, (2) average age at polyp onset of 15 years, and (3) 100 percent risk of colon cancer if left untreated by the fourth decade. The author provides information on managing HNPCC and FAP. When a hereditary colon cancer syndrome is diagnosed families can benefit from genetic counseling and genetic testing. The author concludes that women's health nurses are in an ideal position to promote and support the cancer screening recommendations and to help with overcoming barriers to screening among female mutation carriers. 2 figures, 2 tables, 15 references. ·
One-time Screening for Colorectal Cancer With Combined Fecal Occult-blood Testing and Examination of the Distal Colon Source: New England Journal of Medicine. 345(8):555-560, August 23, 2001. Summary: Researchers examined the effectiveness of one-time screening with the fecal occult blood test (FOBT) combined with examination of the distal colon by sigmoidoscopy (SIG) for detecting colorectal cancer (CRC). They recruited 3,121 asymptomatic patients seen at 13 Veterans Affairs centers between February 1994 and January 1997 for the study. The patients provided 3 consecutive days of stool samples on cards for FOBT testing; samples were rehydrated for interpretation. The patients then underwent colonoscopy (COL). Researchers considered examination of the rectum and sigmoid colon during COL as SIG. Of the 3,121 participants, 2,885 returned their FOBT cards before COL. The mean age of this group was 63.0 years, 96.8 percent were men, and 14.2 percent reported having a first degree relative with CRC. Results indicated that 1,319 participants (45.7 percent) had no polypoid lesions. In 472 (16.4 percent), the most advanced lesions were hyperplastic polyps or nonadenomatous polyps, and in 788 (27.3 percent), the most advanced finding was one or more tubular adenomas less than 10 millimeters in diameter. Advanced neoplasia was detected in 306 patients (10.6 percent). Of these, 182 had advanced neoplasia in the distal colon and 150 in the proximal colon. Altogether, 143 had one or more large tubular adenomas, 90 had an adenoma with villous features, 49 had an adenoma with high-grade dysplasia, and 24 had invasive cancer. Seventy-three patients (23.9 percent) with advanced neoplasia had a positive FOBT. When compared with patients who had a negative FOBT, the relative risk of advanced neoplasia in patients with a positive FOBT was 3.47. SIG identified 70.3 percent of all patients with advanced neoplasia. Combined one-time screening with FOBT and SIG identified 75.8 percent of patients with advanced neoplasia. Researchers conclude that one-time screening of asymptomatic persons with the FOBT plus SIG fails to identify about
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one quarter of those with advanced neoplasia and about half of those with advanced proximal neoplasia. Clinicians should not feel confident that advanced neoplasia can be ruled out when the results of one-time combined testing are negative. Screening programs that use FOBT plus SIG may be more effective if the tests are repeated at appropriate intervals. 4 tables, 21 references. ·
Screening for Colorectal Cancer: Developing a Preventive Healthcare Program Utilizing Nurse Endoscopists Source: Gastroenetrology Nursing. 24(1):12-19, January-February 2001. Summary: The authors discuss screening for colorectal cancer (CRC) and the development of a CRC screening program incorporating nurse endoscopists at Northwestern Memorial Hospital (NMH), Chicago, Illinois. The program was developed and implemented during the creation of the Colon Cancer Screening Center (CCSC), a component of NMH's comprehensive gastrointestinal oncology program in 1997. The goals of the CCSC's CRC screening program were to (1) provide a unique early cancer detection program in the Chicago metropolitan area, (2) become a leader in early detection of CRC through screening, (3) provide a referral service to physicians within NMH that provides screening and preventive health education, and (4) develop a clinical database to track clinical outcomes and trends in patient compliance. The authors discuss aspects of developing the program that may be useful for other institutions interested in developing a similar program, including (1) the institutional marketing research process, (2) training nurse endoscopists and developing benchmark data to evaluate their training, (3) operational planning/advertising strategies, (4) implementing a program similar to the CCSC-based program, and (5) program evaluation. To date, 745 patients age 50 to 64 years old have been screened. Of these, 14 percent were referred for colonoscopy for multiple polyps or adenomas. One rectal carcinoma was identified. There were no complications from the procedures. 4 tables, 11 references.
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Virtual Colonoscopy: A New Approach for Colorectal Cancer Screening Source: Gastroenterology Nursing. 24(1):5-11, January-February 2001. Summary: The author discusses virtual colonoscopy (VC) as a new approach for colorectal cancer (CRC) screening. The article (1) presents background information on CRC screening; (2) summarizes the American Cancer Society (ACS) guidelines for CRC screening; (3) discusses the various types of VC, including a summary of clinical studies of VC; (4) discusses safety issues of VC; (5) discusses the procedural aspects of VC;
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(6) discusses the advantages of VC relative to standard colonoscopy (SC); (7) summarizes the challenges of VC; and (8) considers future implications of CRC screening with VC. VC is a tomographic technique that can display computer images of the colon in an anatomical life-like format to facilitate image interpretation and improve diagnostic accuracy. There are three types of VC: (1) Computed tomography (CT) pneumocolonoscopy, (2) CT colography, and (3) VC. All three techniques use bowel cleansing, air insufflation, smooth muscle relaxation, and helical CT data acquisition. The differences between the procedures stem from the manner in which the data are manipulated. In CT pneumocolonoscopy, CT data are interpreted in the conventional radiologic manner. CT colography involves a CT of the colon in which a small section is examined and displayed in a two-dimensional image, supplemented with three-dimensional images. VC is the interactive realtime navigation through the colon to simulate SC. Approximately 2,000 VC examinations have been performed worldwide. VC has been reported to have a sensitivity of 80 percent for detecting CRC and polyps greater than 10 millimeter. Its specificity has been reported to be 90 percent. An advantage of VC is that it does not require sedation. No perforations have been reported with VC. VC has the potential to examine the entire colon in substantially less time than SC. Although VC is comfortable for the patient, the patient still has to undergo a bowel preparation similar to that required for SC. The amount and time of insufflation, however, is less than that of SC, producing less discomfort for the patient. The author notes that VC appears to have tremendous potential for improving patient acceptance as a screening method for CRC. VC also appears to be an excellent method for implementing the current ACS guidelines for screening men and women at average risk for CRC beginning at age 50. 3 figures, 1 table, 39 references. ·
Use of Colonoscopy to Screen Asymptomatic Adults for Colorectal Cancer Source: Gastrointestinal Endoscopy. 53(7):832-834, June 2001. Summary: The first two authors discuss the results of two large studies evaluating the reliability and accuracy of different methods of screening for colorectal cancer. The first study indicated that 2.7 percent of patients with no polyps in the portion of the colon distal to the splenic flexure had advanced proximal neoplasms. The other study found that a distal adenoma was not a reliable predictor of advanced proximal neoplasia; only 46 percent of patients with an advanced proximal lesion had a distal polyp that would have been detected by screening sigmoidoscopy. In another study on double contrast barium enema, only 48 percent of large
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adenomas found by colonoscopy were detected by barium enema. The authors conclude that the most accurate and reliable evaluation currently available is colonoscopy. In a response, Lieberman discusses issues of effectiveness, risk, cost, and resources that need to be considered before embracing colonoscopy as a primary screening tool. A response by Imperiale and Ransohoff indicates that they do not consider that the data from these studies justifies a recommendation for universal colonoscopy. Instead, the two studies should be scrutinized for strength and robustness, supplemented by an assessment of whether additional studies of colonoscopic screening are still needed. Information on risk factors should be used to stratify risk among those now considered average-risk persons. Colonoscopy could be extended to increased-risk persons, while its use among average-risk persons could be deferred. ·
Colorectal Cancer Screening in North Carolina: Community Clinicians' Perspectives Source: North Carolina Medical Journal. 62(5):292-297, SeptemberOctober, 2001. Summary: Researchers conducted a survey to assess community clinicians' perspectives on colorectal cancer screening in North Carolina. Between November 1997 and May 1998, they sent a self-administered questionnaire to family practitioners, general practitioners, and general internists who were actively practicing in primary care settings. The questionnaire assessed (1) personal characteristics, (2) practices of colon cancer screening with fecal occult blood testing (FOBT) and flexible sigmoidoscopy (FS), and (3) attitudes toward and barriers to using FS. Of 1,333 physicians contacted, 736 (55 percent) provided usable responses. Results showed that (1) most respondents were male family practitioners in group practice; (2) 97 percent recommended periodic screening with FOBT; (3) of those recommending FOBT, 35 percent said that annual screening should start at age 50 years; and (4) 79 percent thought that the proper screening interval was once a year. Other results showed that (1) 92 percent recommended screening with FS, (2) 43 percent performed FS themselves, and (3) 85 percent agreed with recommendations that screening with FS should begin at age 50 years and be repeated every 3 to 5 years. Perceived barriers to FS differed according to respondents' experience with the procedure. Among practitioners who recommended FS but did not perform this procedure themselves, barriers included time constraints, equipment costs, inadequate reimbursement, and regulatory restrictions. Half of the respondents had received training in FS as medical residents. The most common perceived patient barrier to FOBT was inconvenience, and to FS was fear of pain and discomfort. The
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researchers conclude that there is a need to find ways to encourage physicians to promote colorectal cancer screening to their patients. 4 tables, 20 references. ·
Colon Cancer Screening With Virtual Colonoscopy: Promise, Polyps, Politics Source: American Journal of Roentgenology. 177(5):975-988, November 2001. Summary: The author discusses virtual colonoscopy as a potential primary means of screening for colon cancer, which could return radiologists to a major role in the prevention of colon cancer. Research suggests that its accuracy is comparable to conventional colonoscopy in detecting polyps of significant size (greater than 10 mm), with few false positives. Virtual colonoscopy has heightened awareness of the natural history of colonic polyps, especially in terms of identifying an appropriate target size for detection in colorectal screening programs. Polyps under 10 mm are often either hyperplastic on histology or unlikely to progress to frank cancer in the patient's lifetime, so they are of little clinical significance for the average adult. The rationale for detecting and removing every colonic polyp regardless of size has come under increasing scrutiny in the context of cost-benefit analysis of various test strategies for colorectal cancer screening. Virtual colonoscopy may allow patients to receive reliable information about the status of their colonic mucosa noninvasively, therefore making more informed decisions about whether to proceed to conventional colonoscopy for polypectomy. Cancer researchers are working to improve the speed of image analysis, use of computer-assisted methods for polyp detection, magnetic resonance colonography, and oral contrast tagging of fecal contents in order to avoid the need for rigorous bowel preparation, thus improving patient compliance. 10 figures, 3 tables, 87 references.
Federally Funded Research on Colon Cancer The U.S. Government supports a variety of research studies relating to colon cancer and associated conditions. These studies are tracked by the Office of Extramural Research at the National Institutes of Health.26 CRISP
Healthcare projects are funded by the National Institutes of Health (NIH), Substance Abuse and Mental Health Services (SAMHSA), Health Resources and Services Administration (HRSA), Food and Drug Administration (FDA), Centers for Disease Control 26
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(Computerized Retrieval of Information on Scientific Projects) is a searchable database of federally funded biomedical research projects conducted at universities, hospitals, and other institutions. Visit the CRISP Web site at http://commons.cit.nih.gov/crisp3/CRISP.Generate_Ticket. You can perform targeted searches by various criteria including geography, date, as well as topics related to colon cancer and related conditions. For most of the studies, the agencies reporting into CRISP provide summaries or abstracts. As opposed to clinical trial research using patients, many federally funded studies use animals or simulated models to explore colon cancer and related conditions. In some cases, therefore, it may be difficult to understand how some basic or fundamental research could eventually translate into medical practice. The following sample is typical of the type of information found when searching the CRISP database for colon cancer: ·
Project Title: Apoptosis in Colon Cancer Chemoprevention Principal Investigator & Institution: Gerner, Eugene W.; Professor; None; University of Arizona Tucson, Az 85721 Timing: Fiscal Year 2001; Project Start 1-JUL-1997; Project End 1-DEC2005 Summary: Colon cancer remains the second leading cause of cancer death in the United States of America, affecting both males and females. The major theme of this program is the study of apoptosis in colon carcinogenesis and colon cancer chemoprevention. Studies in experimental rodent models and humans indicate that genetic and intestinal luminal risk factors decrease cell turnover, in part by decreasing apoptosis, in normal and neoplastic colonic tissues. Intestinal luminal risk factors include the secondary bile acids, which are affected by both genetic and dietary factors. Our program addresses both genetic and intestinal luminal risk factors, as we hypothesize that common signaling and metabolic pathways downstream of both these factors mediate cell turnover in colonic tissues and, subsequently, colon cancer risk. A corollary of this hypothesis is that these downstream pathways are rational targets for colon cancer chemoprevention strategies in humans. To test this hypothesis, we have designed projects and cores that are interactive and complementary. One project studies biochemical effectors of genes, including the Ki-ras oncogene and the APC and p53 tumor suppressor genes, which are frequently mutated in human colon cancers. A second project focuses on the role of nitric oxide in bile acid
and Prevention (CDCP), Agency for Healthcare Research and Quality (AHRQ), and Office of Assistant Secretary of Health (OASH).
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induced apoptosis. The third project emphasizes studies of the AP-1 transcription factor, which is involved in signaling pathways mediated by both APC and bile acids. The specific aims of the projects are to determine the roles of genetic and intestinal luminal risk factors in cell turnover in colonic tissues, to describe mechanisms underlying these processes, and to investigate the consequences of specific pharmacological and/or dietary interventions on cell turnover and colon carcinogenesis. The projects will address these aims using genetically altered cell culture and rodent models of colon cancer, and a variety of biochemical, molecular and cellular biology technologies. Four cores provide support in cell and tissue pathology, breeding and maintaining genetically altered rodent models of colon carcinogenesis, biometry and administration and evaluation. The long-term goal of the Apoptosis in Colon Cancer Chemoprevention Program Project Grant is to understand mechanisms of colon carcinogenesis in humans and then to use this information to establish the rational for strategies of colon cancer prevention and/or treatment. Website: http://commons.cit.nih.gov/crisp3/CRISP.Generate_Ticket ·
Project Title: Biological Evaluation of ZD1839 in Colon Cancer Principal Investigator & Institution: Hidalgo, Manuel; Associate Professor of Oncology; Oncology; Johns Hopkins University 3400 N Charles St Baltimore, Md 21218 Timing: Fiscal Year 2002; Project Start 9-SEP-2002; Project End 1-AUG2004 Summary: (provided by applicant): The epidermal growth factor receptor (EGFR) is a transmembrane receptor involved in the transduction of proliferative and survival signals which is overexpressed in up to 50 % of patients with colon cancer. Preclinical data suggest that pharmacological inhibition of the EGFR results in tumor growth inhibition and, therefore, the EGFR represents a potential target for cancer therapy. ZD1839 is a novel, orally available, small molecule inhibitor of the EGFR in clinical development. Important questions in the development of this agent, as well as other mechanistic based compounds are the definition of patient populations more likely to respond to the drug based on the presence and functionality of the target pathway in tumor tissues and the assessment of target inhibition in clinical trials. This proposal outlines a series of clinical, pharmacological and biological studies of ZD1839 in patients with colon cancer. Our long term goal is to develop ZD1839 for the treatment of patients with colon cancer, as well as with other EGFRdriven tumors, utilizing rationally derived biological concepts based on the putative mechanism of action of the agent. The specific aims of this
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proposal are: Specific Aim # 1: to determine the relationship between expression and activation of the EGFR receptor in malignant tissues and the activity of ZD1839 in patients with colon cancer, Specific Aim # 2: to characterize the effects of ZD1839 on the activation and signaling of the EGFR in tumor and normal tissues of patients with colon cancer who are treated with ZD1839; and, Specific Aim # 3: to relate the pharmacodynamic effects of ZD 1839 to relevant indices of clinical activity. Patients with advanced, measurable, colon cancer will be treated with ZD1839 at a dose of 500 mg/day on a protracted oral dosing schedule. Tumor tissues, normal skin tissues, and plasma will be collected at baseline and 28 days post-treatment. The expression and activation of the EGFR will be determined using validated immunohistochemical methods developed at our institutions. The result from the biological studies will be correlated with indices of drug activity. These results will provide hypothesis-generating data regarding the subset of colon cancer patients more likely to benefit from treatment with this agent as well as information regarding the biological activity of ZD1839 in colon cancer. Collectively, these data will impact in the future development of ZD1839 in patients with colon cancer as well as other tumor types. Website: http://commons.cit.nih.gov/crisp3/CRISP.Generate_Ticket ·
Project Title: Gene Expression Changes in Metastatic Colon Cancer Principal Investigator & Institution: Guan, Rong J.; Beth Israel Deaconess Medical Center 330 Brookline Ave Boston, Ma 02215 Timing: Fiscal Year 2000; Project Start 1-APR-2000; Project End 1-OCT2000 Summary: The most life-threatening aspects of colon cancer are invasion and metastasis. Genetic alterations likely play a crucial role in the pathogenesis of colon cancer metastasis. Therefore, one of the most important issues in cancer research is to understand the genetic alterations in metastasis. The goal of this application is to analyze gene expression changes in metastatic colon cancer. By using differential display, we have identified 19 genes expressed differentially between primary and metastatic colon cancer. In preliminary studies, we found that a novel gene called 055 is not expressed in metastatic colon cancer tissues or a metastatic colon cancer cell line (SW620). Overexpression of 055 in SW620 increased expression of several cell differentiation markers such as E-cadherin, CEA and alkaline phosphatase and induced morphological changes consistent with cell differentiation. The expression of 055 is upregulated by several known cell differentiation reagents. Our preliminary studies show that overexpression of 055 in
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SW620 colon cancer cells suppressed in vitro invasion into matrigel and in vivo liver metastasis in nude mice. Our workings hypothesis is that the 055 gene suppresses metastasis by inducing colon cancer cell differentiation and reversing the malignant phenotype. Therefore, we propose: (1) to investigate the expression and function of 055 protein in normal and neoplastic colonic epithelial cells. This will include studying: (a) subcellular localization of the 055 gene in colon cancer cell lines; the expression of 055 protein in normal colon tissues, adenomas, primary and metastatic colon cancers by immunohistochernistry. (b) the in vitro and in vivo adhesion and invasion properties of metastatic colon cancer cells transfected with 055 gene, or primary colon cancer cells transfected with 055 antisense DNA; (c) the mechanism of 055 in regulation of E-cadherin expression and cell differentiation. (2) to study the mechanism of aberrant regulation of 055 gene in metastaric colon cancer. This will be accomplished by: (a) nuclear run-off assay to determine the rate of transcription. Should run-off assay and promoter studies fail to detect difference in rate of transcription between primary and metastatic colon cancer cells, a mRNA decay assay to assess the mRNA stability will be performed. (B) cloning and analyzing the promoter region of the 055 gene. Chloramphenicol acetyltransferase (CAT) gene assay will be used to assess the activities of normal 055 promoter in both primary and metastatic colon cancer cells. (c) Analyzing the role of DNA methylation in regulation of 055 expression. Website: http://commons.cit.nih.gov/crisp3/CRISP.Generate_Ticket ·
Project Title: Gene Expression of Colon Cancers That Metastasize Principal Investigator & Institution: Markowitz, Sanford D.; Ingalls Professor of Cancer Genetics; Medicine; Case Western Reserve University 10900 Euclid Ave Cleveland, Oh 44106 Timing: Fiscal Year 2000; Project Start 0-AUG-2000; Project End 1-JAN2005 Summary: This proposal will test the hypothesis that differences in patterns of gene expression determine the differing biologic behaviors between colon cancers that are curable with primary surgical therapy and those that ultimately metastasize to the liver and kill. Additionally, we hypothesize that in colon cancer primary tumors, only a minority of cells will be "prometastatic", that is competent to give rise to liver metastases, and that assays of whole primary tumor lysates may thus fail to distinguish the crucial presence or absence of this "prometastatic" subpopulation. To test these hypotheses, Dr. Sanford Markowitz and his colleagues in the cancer genetics program at the Case Western Reserve University-NCI designated Comprehensive Cancer Center have forged a
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collaboration with Eos Biotechnology, Inc., a leader in gene expression array technology. The collaboration aims to establish an accurate molecular classification of colon cancer by focusing on a unique collection of surgically resected colon cancer liver metastases, all of whose cells have in vivo demonstrated metastatic ability. Using the Affymetrix human 40K GeneChip expression array technology, these investigators will generate a comprehensive description of global gene expression of these liver metastases. Comparing these liver metastases versus control nonmetastatic colon cancers, that were all cured by surgical excision, will specify a set of metastases specific genes whose expression defines a "metastatic signature." The goal of identifying those colon cancer primary tumors that can metastasize will be achieved by showing that they bear "prometastatic" cells recognizable by in situ hybridization assay of "metastatic signature" genes. Project aims are: i) To elucidate the "metastatic signature" by comparing on Affymetrix arrays colon cancer liver metastases versus non-metastatic colon cancer primary tumors. ii) To identify among metastases signature genes those specifying early metastatic events detectable by array analyses of colon cancer primary tumors that did metastasize. iii) To use in situ hybridization to confirm the metastatic signature of liver metastases arises from colon epithelial cells. iv) To use in situ hybridization to detect expression of metastatic signature genes by prometastatic cells in colon cancer primary tumors that are simultaneous with lever metastases or are precursor of liver metastases relapse. v) To use in situ hybridization to determine the areas of maximum concentration of "prometastatic" cells in colon cancer primary tumors. vi) To validate the metastatic signature and show it has prognostic power in an independent validation archive of 350 colon cancers. vii) To develop immunohistochemical assays for detection of the metastatic signature. Website: http://commons.cit.nih.gov/crisp3/CRISP.Generate_Ticket
E-Journals: PubMed Central27 PubMed Central (PMC) is a digital archive of life sciences journal literature developed and managed by the National Center for Biotechnology Information (NCBI) at the U.S. National Library of Medicine (NLM).28 Access Adapted from the National Library of Medicine: http://www.pubmedcentral.nih.gov/about/intro.html. 28 With PubMed Central, NCBI is taking the lead in preservation and maintenance of open access to electronic literature, just as NLM has done for decades with printed biomedical literature. PubMed Central aims to become a world-class library of the digital age. 27
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to this growing archive of e-journals is free and unrestricted.29 To search, go to http://www.pubmedcentral.nih.gov/index.html#search, and type “colon cancer” (or synonyms) into the search box. This search gives you access to full-text articles. The following is a sample of items found for colon cancer in the PubMed Central database: ·
Cell Cycle Regulation of Metallothionein in Human Colonic Cancer Cells by WW Nagel and BL Vallee; 1995 January 17 http://www.pubmedcentral.nih.gov/articlerender.fcgi?rendertype=abst ract&artid=42785
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Controversy:Population-based fecal occult blood screening for colon cancer: Will the benefits outweigh the harm? by Kenneth G. Marshall; 2000 September 5 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=80462
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CpG island methylator phenotype in colorectal cancer by Minoru Toyota, Nita Ahuja, Mutsumi Ohe-Toyota, James G. Herman, Stephen B. Baylin, and Jean-Pierre J. Issa; 1999 July 20 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=17576
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Cyclooxygenase-2 expression in human colon cancer cells increases metastatic potential by Masahiko Tsujii, Sunao Kawano, and Raymond N. DuBois; 1997 April 1 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=20370
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De novo Decorin Gene Expression Suppresses the Malignant Phenotype in Human Colon Cancer Cells by M Santra, T Skorski, B Calabretta, EC Lattime, and RV Iozzo; 1995 July 18 http://www.pubmedcentral.nih.gov/articlerender.fcgi?rendertype=abst ract&artid=41462
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Distinct Hypermethylation Patterns Occur at Altered Chromosome Loci in Human Lung and Colon Cancer by M Makos, BD Nelkin, MI Lerman, F Latif, B Zbar, and SB Baylin; 1992 March 1 http://www.pubmedcentral.nih.gov/articlerender.fcgi?rendertype=abst ract&artid=48567
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Effect of 2[prime prime or minute]-O-methyl antisense ORNs on expression of thymidylate synthase in human colon cancer RKO cells by John C. Schmitz, Dong Yu, Sudhir Agrawal, and Edward Chu; 2001 January 15 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=29681
The value of PubMed Central, in addition to its role as an archive, lies the availability of data from diverse sources stored in a common format in a single repository. Many journals already have online publishing operations, and there is a growing tendency to publish material online only, to the exclusion of print. 29
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Epidermal growth factor receptor activation induces nuclear targeting of cyclooxygenase-2, basolateral release of prostaglandins, and mitogenesis in polarizing colon cancer cells by Robert J. Coffey, Chris J. Hawkey, Lars Damstrup, Ramona Graves-Deal, Vincent C. Daniel, Peter J. Dempsey, Rebecca Chinery, Susan C. Kirkland, Raymond N. DuBois, Thomas L. Jetton, and Jason D. Morrow; 1997 January 21 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=19569
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ETS1 Suppresses Tumorigenicity of Human Colon Cancer Cells by H Suzuki, V Romano-Spica, TS Papas, and NK Bhat; 1995 May 9 http://www.pubmedcentral.nih.gov/articlerender.fcgi?rendertype=abst ract&artid=41960
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Fine Mapping of Colon Tumor Susceptibility (Scc) Genes in the Mouse, Different from the Genes Known to be Somatically Mutated in Colon Cancer by CJA Moen, PC Groot, AAM Hart, M Snoek, and P Demant; 1996 February 6 http://www.pubmedcentral.nih.gov/articlerender.fcgi?rendertype=abst ract&artid=40034
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Frameshift-mutation-derived peptides as tumor-specific antigens in inherited and spontaneous colorectal cancer by Ingvil Saeterdal, Jens Bjorheim, Kari Lislerud, Marianne K. Gjertsen, Ida K. Bukholm, Ole Christian Olsen, Jahn M. Nesland, Jon Amund Eriksen, Mona Moller, Annika Lindblom, and Gustav Gaudernack; 2001 November 6 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=60857
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Genetic disruption of PPAR[delta] decreases the tumorigenicity of human colon cancer cells by Ben Ho Park, Bert Vogelstein, and Kenneth W. Kinzler; 2001 February 27 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=30184
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Hereditary nonpolyposis colon cancer by Edmond G. Lemire; 2001 November 13 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=81612
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High Expression of the DNA Methyltransferase Gene Characterizes Human Neoplastic Cells and Progression Stages of Colon Cancer by WS El-Deiry, BD Nelkin, P Celano, RC Yen, JP Falco, SR Hamilton, and SB Baylin; 1991 April 15 http://www.pubmedcentral.nih.gov/articlerender.fcgi?rendertype=abst ract&artid=51469
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HLTF gene silencing in human colon cancer by Helen R. Moinova, WeiDong Chen, Lanlan Shen, Dominic Smiraglia, Joseph Olechnowicz, Lakshmeswari Ravi, Lakshmi Kasturi, Lois Myeroff, Christoph Plass,
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Ramon Parsons, John Minna, James K. V. Willson, Sylvan B. Green, JeanPierre Issa, and Sanford D. Markowitz; 2002 April 2 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=123687 ·
Human Colorectal Cancers Display Abnormal Fourier-Transform Infrared Spectra by B Rigas, S Morgello, IS Goldman, and PTT Wong; 1990 October 15 http://www.pubmedcentral.nih.gov/articlerender.fcgi?rendertype=abst ract&artid=54908
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JC virus DNA is present in the mucosa of the human colon and in colorectal cancers by Luigi Laghi, Ann E. Randolph, D. P. Chauhan, Giancarlo Marra, Eugene O. Major, James V. Neel, and C. Richard Boland; 1999 June 22 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=22112
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Limited Up-Regulation of DNA Methyltransferase in Human Colon Cancer Reflecting Increased Cell Proliferation by PJ Lee, LL Washer, DJ Law, CR Boland, IL Horon, and AP Feinberg; 1996 September 17 http://www.pubmedcentral.nih.gov/articlerender.fcgi?rendertype=abst ract&artid=38390
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Liver Colonization Competence Governs Colon Cancer Metastasis by T Kuo, T Kubota, M Watanabe, T Furukawa, T Teramoto, K Ishibiki, M Kitajima, AR Moosa, S Penman, and RM Hoffman; 1995 December 19 http://www.pubmedcentral.nih.gov/articlerender.fcgi?rendertype=abst ract&artid=40301
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Mad-1 Is the Exclusive JC Virus Strain Present in the Human Colon, and Its Transcriptional Control Region Has a Deleted 98-Base-Pair Sequence in Colon Cancer Tissues by Luigi Ricciardiello, Dong K. Chang, Luigi Laghi, Ajay Goel, Christina L. Chang, and C. Richard Boland; 2001 February 15 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=115147
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Models of Human Metastatic Colon Cancer in Nude Mice Orthotopically Constructed by Using Histologically Intact Patient Specimens by X Fu, JM Besterman, A Monosov, and RM Hoffman; 1991 October 15 http://www.pubmedcentral.nih.gov/articlerender.fcgi?rendertype=abst ract&artid=52711
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Molecular karyotype (amplotype) of metastatic colorectal cancer by unbiased arbitrarily primed PCR DNA fingerprinting by Sergei Malkhosyan, Jun Yasuda, Jose Luis Soto, Takao Sekiya, Jun Yokota, and Manuel Perucho; 1998 August 18 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=21480
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Nuclear Matrix Proteins in Human Colon Cancer by SK Keesee, MD Meneghini, RP Szaro, and Y Wu; 1994 March 1 http://www.pubmedcentral.nih.gov/articlerender.fcgi?rendertype=abst ract&artid=43274
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p21WAF1 is required for butyrate-mediated growth inhibition of human colon cancer cells by Sonia Y. Archer, Shufen Meng, Amy Shei, and Richard A. Hodin; 1998 June 9 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=22637
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p53 Mutations in Colorectal Cancer by NR Rodrigues, A Rowan, MEF Smith, IB Kerr, WF Bodmer, JV Gannon, and DP Lane; 1990 October 1 http://www.pubmedcentral.nih.gov/articlerender.fcgi?rendertype=abst ract&artid=54786
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Patterns of Gene Expression that Characterize the Colonic Mucosa in Patients at Genetic Risk for Colonic Cancer by LH Augenlicht, J Taylor, L Anderson, and M Lipkin; 1991 April 15 http://www.pubmedcentral.nih.gov/articlerender.fcgi?rendertype=abst ract&artid=51431
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Potential role and chronology of abnormal expression of the Deleted in Colon Cancer (DCC) and the p53 proteins in the development of gastric cancer by Francesco Graziano, Stefano Cascinu, Maria Pia Staccioli, Vincenzo Catalano, Maria Cristina Rossi, Anna Maria Baldelli, Paolo Giordani, Pietro Muretto, and Giuseppina Catalano; 2001 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=37544
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Prostacyclin-mediated activation of peroxisome proliferator-activated receptor [delta] in colorectal cancer by Rajnish A. Gupta, Jian Tan, Wade F. Krause, Mark W. Geraci, Timothy M. Willson, Sudhansu K. Dey, and Raymond N. DuBois; 2000 November 21 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=27215
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Prostaglandin H Synthase 2 is Expressed Abnormally in Human Colon Cancer: Evidence for a Transcriptional Effect by W Kutchera, DA Jones, N Matsunami, J Groden, TM McIntyre, GA Zimmerman, RL White, and SM Prescott; 1996 May 14 http://www.pubmedcentral.nih.gov/articlerender.fcgi?rendertype=abst ract&artid=39362
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Receptor protein tyrosine kinase EphB4 is up-regulated in colon cancer by Sally-Anne Stephenson, Stefan Slomka, Evelyn L. Douglas, Peter J. Hewett, and Jennifer E. Hardingham; 2001 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=64642
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Synchronous Cardiac Myxoma and Colorectal Cancer: A Case Report by Ismael N. Nuno, Tyler Y. Kang, Hector Arroyo, and Vaughn A. Starnes; 2001 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=101182
The National Library of Medicine: PubMed One of the quickest and most comprehensive ways to find academic studies in both English and other languages is to use PubMed, maintained by the National Library of Medicine. The advantage of PubMed over previously mentioned sources is that it covers a greater number of domestic and foreign references. It is also free to the public.30 If the publisher has a Web site that offers full text of its journals, PubMed will provide links to that site, as well as to sites offering other related data. User registration, a subscription fee, or some other type of fee may be required to access the full text of articles in some journals. To generate your own bibliography of studies dealing with colon cancer, simply go to the PubMed Web site at www.ncbi.nlm.nih.gov/pubmed. Type “colon cancer” (or synonyms) into the search box, and click “Go.” The following is the type of output you can expect from PubMed for “colon cancer” (hyperlinks lead to article summaries): ·
#12 Limited social support or religious involvement as risk factors for colon cancer. Author(s): Kinney A, Marshall E, Dudley W, Martin C, Sandler R. Source: Annals of Epidemiology. 2002 October; 12(7): 494. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12377438&dopt=Abstract
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A new TNM staging strategy for node-positive (stage III) colon cancer: an analysis of 50,042 patients. Author(s): Greene FL, Stewart AK, Norton HJ. Source: Annals of Surgery. 2002 October; 236(4): 416-21; Discussion 421. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12368669&dopt=Abstract
PubMed was developed by the National Center for Biotechnology Information (NCBI) at the National Library of Medicine (NLM) at the National Institutes of Health (NIH). The PubMed database was developed in conjunction with publishers of biomedical literature as a search tool for accessing literature citations and linking to full-text journal articles at Web sites of participating publishers. Publishers that participate in PubMed supply NLM with their citations electronically prior to or at the time of publication.
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A novel lymphatic mapping technique to improve localization and staging of early colon cancer during laparoscopic colectomy. Author(s): Tsioulias GJ, Wood TF, Spirt M, Morton DL, Bilchik AJ. Source: The American Surgeon. 2002 July; 68(7): 561-5. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12132733&dopt=Abstract
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Activity and properties of alpha-L-fucosidase are dependent on the state of enterocytic differentiation of HT-29 colon cancer cells. Author(s): Merino-Trigo A, Rodriguez-Berrocal FJ, de Miguel E, Paez de la Cadena M. Source: The International Journal of Biochemistry & Cell Biology. 2002 October; 34(10): 1291-303. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12127580&dopt=Abstract
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Adenovirus-mediated gene transfer of P16INK4/CDKN2 into baxnegative colon cancer cells induces apoptosis and tumor regression in vivo. Author(s): Tamm I, Schumacher A, Karawajew L, Ruppert V, Arnold W, Nussler AK, Neuhaus P, Dorken B, Wolff G. Source: Cancer Gene Therapy. 2002 August; 9(8): 641-50. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12136424&dopt=Abstract
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Adjuvant Chemotherapy in Stage III Colon Cancer with 5-Fluorouracil and Levamisole versus 5-Fluorouracil and Leucovorin. Author(s): Dencausse Y, Hartung G, Sturm J, Kopp-Schneider A, Hagmuller E, Wojatschek C, Lindemann H, Fritze D, Queisser W. Source: Onkologie. 2002 October; 25(5): 426-430. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12415196&dopt=Abstract
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Adjuvant Chemotherapy Use for Medicare Beneficiaries With Stage II Colon Cancer. Author(s): Schrag D, Rifas-Shiman S, Saltz L, Bach PB, Begg CB. Source: Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology. 2002 October 1; 20(19): 3999-4005. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12351597&dopt=Abstract
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Angiogenesis inhibitor TNP-470 suppresses growth of peritoneal disseminating foci of human colon cancer line Lovo. Author(s): Fan YF, Huang ZH. Source: World Journal of Gastroenterology : Wjg. 2002 October; 8(5): 853856. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12378629&dopt=Abstract
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Anti-tumor efficacy of a novel antisense anti-MDM2 mixed-backbone oligonucleotide in human colon cancer models: p53-dependent and p53-independent mechanisms. Author(s): Wang H, Nan L, Yu D, Lindsey JR, Agrawal S, Zhang R. Source: Molecular Medicine (Cambridge, Mass.). 2002 April; 8(4): 185-99. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12149568&dopt=Abstract
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Apoptosis induced by activation of peroxisome-proliferator activated receptor-gamma is associated with Bcl-2 and NF-kappaB in human colon cancer. Author(s): Chen GG, Lee JF, Wang SH, Chan UP, Ip PC, Lau WY. Source: Life Sciences. 2002 April 19; 70(22): 2631-46. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12269390&dopt=Abstract
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Are high-volume surgeons and hospitals the most important predictors of in-hospital outcome for colon cancer resection? Author(s): Ko CY, Chang JT, Chaudhry S, Kominski G. Source: Surgery. 2002 August; 132(2): 268-73. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12219022&dopt=Abstract
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Base excision repair as a therapeutic target in colon cancer. Author(s): Liu L, Nakatsuru Y, Gerson SL. Source: Clinical Cancer Research: an Official Journal of the American Association for Cancer Research. 2002 September; 8(9): 2985-91. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12231545&dopt=Abstract
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Bile acids mimic oxidative stress induced upregulation of thioredoxin reductase in colon cancer cell lines. Author(s): Lechner S, Muller-Ladner U, Schlottmann K, Jung B, McClelland M, Ruschoff J, Welsh J, Scholmerich J, Kullmann F.
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Source: Carcinogenesis. 2002 August; 23(8): 1281-8. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12151345&dopt=Abstract ·
Biliary, fecal and plasma deoxycholic acid in rabbit, hamster, guinea pig, and rat: comparative study and implication in colon cancer. Author(s): Kasbo J, Saleem M, Perwaiz S, Mignault D, Lamireau T, Tuchweber B, Yousef I. Source: Biol Pharm Bull. 2002 October; 25(10): 1381-4. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12392101&dopt=Abstract
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Bioinformatics-based discovery of a novel factor with apparent specificity to colon cancer. Author(s): De Young MP, Damania H, Scheurle D, Zylberberg C, Narayanan R. Source: In Vivo. 2002 July-August; 16(4): 239-48. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12224133&dopt=Abstract
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Blockade of Insulin-like Growth Factor I Receptor Function Inhibits Growth and Angiogenesis of Colon Cancer. Author(s): Reinmuth N, Liu W, Fan F, Jung YD, Ahmad SA, Stoeltzing O, Bucana CD, Radinsky R, Ellis LM. Source: Clinical Cancer Research : an Official Journal of the American Association for Cancer Research. 2002 October; 8(10): 3259-69. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12374697&dopt=Abstract
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Cancer-related serological recognition of human colon cancer: identification of potential diagnostic and immunotherapeutic targets. Author(s): Scanlan MJ, Welt S, Gordon CM, Chen YT, Gure AO, Stockert E, Jungbluth AA, Ritter G, Jager D, Jager E, Knuth A, Old LJ. Source: Cancer Research. 2002 July 15; 62(14): 4041-7. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12124339&dopt=Abstract
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Capillary sodium dodecyl sulfate-DALT electrophoresis with laserinduced fluorescence detection for size-based analysis of proteins in human colon cancer cells. Author(s): Hu S, Jiang J, Cook LM, Richards DP, Horlick L, Wong B, Dovichi NJ.
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Source: Electrophoresis. 2002 September; 23(18): 3136-42. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12298085&dopt=Abstract ·
Characterisation of tumour-associated antigens in colon cancer. Author(s): Line A, Slucka Z, Stengrevics A, Silina K, Li G, Rees RC. Source: Cancer Immunology, Immunotherapy: Cii. 2002 December; 51(10): 574-82. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12384809&dopt=Abstract
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Chemoprevention of precursors to colon cancer by dehydroepiandrosterone (DHEA). Author(s): Osawa E, Nakajima A, Yoshida S, Omura M, Nagase H, Ueno N, Wada K, Matsuhashi N, Ochiai M, Nakagama H, Sekihara H. Source: Life Sciences. 2002 April 19; 70(22): 2623-30. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12269389&dopt=Abstract
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Co-expression of CD44v3 and heparanase is correlated with metastasis of human colon cancer. Author(s): Kuniyasu H, Chihara Y, Kubozoe T, Takahashi T. Source: International Journal of Molecular Medicine. 2002 September; 10(3): 333-7. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12165810&dopt=Abstract
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Colon cancer screening in the ambulatory setting. Author(s): Walsh JM, Posner SF, Perez-Stable EJ. Source: Preventive Medicine. 2002 September; 35(3): 209-18. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12202062&dopt=Abstract
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Colon cancer: detection and prevention. Author(s): Loren DE, Lewis J, Kochman ML. Source: Gastroenterology Clinics of North America. 2002 June; 31(2): 56586. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12134619&dopt=Abstract
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Colon cancer: prevention, diagnosis, treatment. Author(s): McCormick D, Kibbe PJ, Morgan SW.
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Source: Gastroenterology Nursing : the Official Journal of the Society of Gastroenterology Nurses and Associates. 2002 September-October; 25(5): 204-11. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12394397&dopt=Abstract ·
COLOR: a randomized clinical trial comparing laparoscopic and open resection for colon cancer. Author(s): Hazebroek EJ. Source: Surgical Endoscopy. 2002 June; 16(6): 949-53. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12163961&dopt=Abstract
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Comments on E. Giovannucci, "Insulin, insulin-like growth factors and colon cancer: a review of the evidence". Author(s): Grant WB. Source: The Journal of Nutrition. 2002 August; 132(8): 2324; Discussion 2325. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12163683&dopt=Abstract
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Conjugated linoleic acid (CLA) inhibits growth of Caco-2 colon cancer cells: possible mediation by oleamide. Author(s): Kim EJ, Jun JG, Park HS, Kim SM, Ha YL, Park JH. Source: Anticancer Res. 2002 July-August; 22(4): 2193-7. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12174903&dopt=Abstract
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Connexin 43, but not connexin 32, is mutated at advanced stages of human sporadic colon cancer. Author(s): Dubina MV, Iatckii NA, Popov DE, Vasil'ev SV, Krutovskikh VA. Source: Oncogene. 2002 July 25; 21(32): 4992-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12118378&dopt=Abstract
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Constipation, anthranoid laxatives, melanosis coli, and colon cancer: a risk assessment using aberrant crypt foci. Author(s): Nascimbeni R, Donato F, Ghirardi M, Mariani P, Villanacci V, Salerni B.
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Source: Cancer Epidemiology, Biomarkers & Prevention : a Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology. 2002 August; 11(8): 753-7. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12163329&dopt=Abstract ·
Cyclooxygenase-2 inhibition augments the hepatic antitumor effect of oral Salmonella typhimurium in a model of mouse metastatic colon cancer. Author(s): Feltis BA, Sahar DA, Kim AS, Saltzman DA, Leonard AS, Sielaff TD. Source: Diseases of the Colon and Rectum. 2002 August; 45(8): 1023-8. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12195185&dopt=Abstract
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Cyclooxygenase-2 overexpression inhibits death receptor 5 expression and confers resistance to tumor necrosis factor-related apoptosisinducing ligand-induced apoptosis in human colon cancer cells. Author(s): Tang X, Sun YJ, Half E, Kuo MT, Sinicrope F. Source: Cancer Research. 2002 September 1; 62(17): 4903-8. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12208739&dopt=Abstract
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Cyclooxygenase-2 Overexpression Reduces Apoptotic Susceptibility by Inhibiting the Cytochrome c-dependent Apoptotic Pathway in Human Colon Cancer Cells. Author(s): Sun Y, Tang XM, Half E, Kuo MT, Sinicrope FA. Source: Cancer Research. 2002 November 1; 62(21): 6323-6328. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12414664&dopt=Abstract
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Decoding the cryptic origins of colon cancer. Author(s): Twombly R. Source: Environmental Health Perspectives. 2002 July; 110(7): A394-5. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12117656&dopt=Abstract
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Determination of histamine in the whole blood of colon cancer patients. Author(s): Previati M, Raspadori A, Bertolaso L, Parmeggiani A, Bindini
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D, Vitali C, Lanzoni I, Corbacella E, Saviano M, Fagioli F, Blo G, Capitani S. Source: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences. 2002 November 25; 780(2): 331-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12401359&dopt=Abstract ·
Diagnosis and management of hereditary colon cancer. Author(s): Cruz-Correa M, Giardiello FM. Source: Gastroenterology Clinics of North America. 2002 June; 31(2): 53749, X. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12134617&dopt=Abstract
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Effectiveness of Adjuvant Fluorouracil in Clinical Practice: A Population-Based Cohort Study of Elderly Patients With Stage III Colon Cancer. Author(s): Iwashyna TJ, Lamont EB. Source: Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology. 2002 October 1; 20(19): 3992-8. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12351596&dopt=Abstract
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Effects of genetic blockade of the insulin-like growth factor receptor in human colon cancer cell lines. Author(s): Adachi Y, Lee CT, Coffee K, Yamagata N, Ohm JE, Park KH, Dikov MM, Nadaf SR, Arteaga CL, Carbone DP. Source: Gastroenterology. 2002 October; 123(4): 1191-204. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12360481&dopt=Abstract
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Efficacy of combination chemotherapy for stage IV colon cancer with extensive peritoneal dissemination and multiple liver metastases: A case report. Author(s): Mukai M, Oida Y, Mukoyama S, Okamoto Y, Ito I, Nakasaki H, Kawai K, Sato S, Makuuchi H. Source: Oncol Rep. 2002 November-December; 9(6): 1
