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Clinical Trials

Clinical trials, designed to help study the safety and effectiveness of new cancer treatments, represent new possibilities. Patients who qualify receive new therapeutic protocols before they are approved as standard therapy.

Cancer patients who enroll in clinical trials are not "experiments" or guinea pigs, they are a vital part of the ongoing campaign to improve cancer treatments. Chemotherapy and other treatments for cancer will continue to advance thanks to those who participate in clinical trials. Unfortunately, only 2 percent of adults with cancer participate in clinical trials. Approximately 70 percent of all children diagnosed with cancer are enrolled in such studies, which is one of the reasons we've seen so many advances in treatment for these young patients. We need to encourage more adults to participate in clinical trials, and make it easier for them to find out about the studies. These carefully controlled and monitored studies offer a new world of potential and hope.

Between the time they emerge from the laboratory and their routine use on cancer patients, investigational therapies go through the following phases:

  • Phase I studies, which generally involve a small number of people, are the first studies on humans. The goal is to see if the treatment is safe, if it has harmful side effects, and how it is best administered. If the results are positive, researchers move on to phase II.

  • Phase II studies are designed to measure the new therapy’s effectiveness in fighting cancer. Only a small number of participants are used. If benefit is demonstrated, it moves on to phase III.

  • Phase III studies examine how the new therapy compares to standard treatments, the "benchmark" for measuring and evaluating new and improved possibilities in treating cancer. These trials may involve hundreds of participants at different hospitals and research centers.

  • In Phase IV studies, the new research becomes an accepted standard treatment in the arsenal used to fight cancer.

Is a clinical trial right for you? Perhaps. For many patients who have already tried existing standard therapies, clinical trials offer additional hope. Participants also know that they are contributing a great deal to help others, down the road. I often think about the people who were among the first to test the chemotherapy that ultimately helped me. Those enrolled in clinical trials are often part of a national effort. These studies involve many patients in different areas and allow physicians and researchers to share and exchange information. But before participating in a clinical trial, it's important to understand its purpose, benefits, risks and side effects. You will be asked to sign an informed consent. However, you are free to leave the study at any time.

The Professor & The Survivor
Vital Options produces a series of brochures,
The Professor & the Survivor®, to humanize the clinical trial experience. Currently, there are two brochures in the series, one on colorectal cancer and one on breast cancer.
To help decide if a clinical trial is right for you,
visit The Professor & The Survivor website.

Remember that investigational therapies and trials are not always completely covered by health insurance and HMOs. Be sure to discuss this with your doctor as you evaluate your possible participation in a clinical study.

Specific clinical trials that may be of interest to cancer patients are available in many hospitals and clinics throughout the United States. Several online resources currently exist for helping patients and their families find specific clinical trials. It is important to search several sources for information because no single listing service lists all the currently available clinical trials. High-quality resources that represent a wide range of available clinical trials are included in the Clinical Trials Links at the top right of this page.

In addition, Vital Options is pleased to list the clinical trials below at the request of the trial sponsors.

Intraoperative Radiotherapy for Breast Cancer Treatment

USC Norris Comprehensive Cancer Center and Hospital.
Target Population:
Person diagnosed with infiltrating ductal carcinoma measuring 3cm or less; 40 years old or older; breast cancer must be treatable with lumpectomy or segmentectomy; no lymph metastasis.
To evaluate partial breast radiotherapy given during surgery as an alternative to conventional whole breast radiotherapy after surgery.
USC Division of Tumor and Endocrine Surgery
Dennis Holmes, MD; 323-865-3105
For additional information, please go to www.targittrial.com

Physical Activity Research Study

Online based.
Target Population:
Childhood cancer survivors who are currently at least 18 years of age.
To learn more about physical activity in young adults who had cancer when they were children or teenagers.
University of Illinois at Chicago
Lorna Finnegan; 800-586-0921; lornaf@uic.edu
Please visit this website for additional information.

Familial Kidney Cancer Research Study

Any location.
Target Population:
Ashkenazi Jewish families with two or more members affected by kidney cancer.
To help identify genes that may contribute to the development of kidney cancer.
National Cancer Institute (NCI) - Urologic Oncology Branch and the Laboratory of Immunobiology at Frederick Cancer Research Facility.
Call Dr. Berton Zbar 800-949-6704
Please visit this website for additional information. Participation in this study requires the completion of a family medical history questionnaire.

Fertility and Breast Cancer Research Study

Online based.
Target Population:
Women between the ages of 18 and 45 with breast cancer and fertility concerns.
To evaluate the association between Internet-based information and support resources on knowledge, social support, and quality of life. Also, the usefulness of the educational materials will be determined and used to help design and provide more timely information for younger women regarding fertility and childbearing in the future.
Young Survival Coalition and Living Beyond Breast Cancer; funded by a grant from the Susan G. Komen Breast Cancer Foundation.
After registering, you will have 8 questionnaires to fill out. It should take less than 30 minutes. You will then have access to Internet-based educational materials and other support resources related to fertility and breast cancer. After reviewing the educational materials and using the resources, you will be asked to fill out the questionnaires a second time.

Thyroid Cancer Study

Any location
Target Population:
Older than 16 years of age and recently diagnosed with papillary or follicular thyroid cancer
To test if the success rate of eliminating all remaining thyroid tissue by a low dose of radiation from radioactive iodine (131-I) can be improved by adding a study medication.
National Institutes of Health (NIH)
One group of patients will receive lithium (the study medication) and the other group will receive a placebo (a pill that neither harms nor helps). All study-related tests and medications are provided at no cost.

    Clinical Trial Links

Provides regularly updated information about federally and privately supported clinical research in human volunteers. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details.

National Cancer Institute
Website provided by the National Cancer Institute for clinical trial information and list of current NCI cancer clinical trials.

Cancer Trials Support Unit (CTSU)
The Cancer Trials Support Unit (CTSU) is an NCI funded program to facilitate participation (by both patients and physicians) in phase III NCI sponsored Cancer treatment trials.

How to Talk With Your Doctor About Cancer Clinical Trials
A Viewpoint interview with Selma R. Schimmel, founder and CEO of Vital Options International and Robert L. Comis, M.D., President and Chairman of the Coalition of National Cancer Cooperative Groups

Oncolink: The University of Pennsylvania Cancer Center
Provides information to cancer patients, families, healthcare professionals and the general public.

The Wellness Community Clinical Trials Matching Service
EmergingMed, on behalf of The Wellness Community, will help you connect to the clinical staff conducting the clinical trials to which you match.

Provides patients with an online directory of clinical trials and cancer information specialists to perform personalized clinical trials searches on behalf of patients.

Offers patient resources, including a listing of clinical trials by disease category, links to current National Institutes of Health (NIH) trials, listings of new FDA drug therapy approvals and current research headlines.

Coalition of Cancer Cooperative Groups
Offers a variety of programs and information for physicians, patient advocate groups, and patients designed to increase awareness of, and participation in, cancer clinical trials.

QuickLink: Colorectal Cancer Clinical Trial Information
17,500 Participants Needed to Enroll in Major Colorectal Cancer Clinical Trials.

GCF and GOG Partner to Provide Information About Gynecologic Oncology Group (GOG) Phase III Clinical Trials
GCF, with grant support from GOG, announces the launch of an addition to the Women’s Cancer Network’s clinical trials section.

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