Huntington Hospital - North Shore - Long Island Jewish Health System

Cancer death rates are falling in the United States. This good news stems partly from patient studies - clinical studies or clinical trials - that over the years have developed better treatments for many different cancers, including breast cancer, colon and rectal cancer, childhood cancers, Hodgkin's disease, and testicular cancer. Today thousands of researchers and patients throughout the United States are involved in clinical trials to continue development of better treatments.

A clinical trial offers the best available treatment and the opportunity to receive a new, and potentially more effective, therapy.

We have clinical trials for the following:

Ovarian Cancer Prevenction
Early Detection Study-Ovarian Cancer
Breast Cancer treatment trials
Gastric Cancer treatment trials
Pancreatic Cancer treatment trials
Prostate Cancer treatment trials
Leukemia and Lymphoma treatment trials
Lung Cancer Treatment trials
Treatment trials to manage the side effects of chemotherapy
Transplant trials for Renal Cell cancer, Mantle Cell Lymphoma and Multiple Myeloma
Radiation therapy treatment trials for lung, prostate, brain, head and neck and anal cancers

What does "clinical trial" mean?

"Clinical trial" is a research term that refers to medical studies with people. These studies are one of the final steps in the process of developing new drugs and other means to fight disease. Once a drug has shown promise, first in laboratory and then in animal studies, it may move on to studies with people if the U. S. Food and Drug Administration (FDA) approves. At this stage, FDA approval is only to conduct the study-not for the drug itself. Only after a drug proves safe and effective in clinical trials does FDA grant approval for marketing the drug.

Clinical trials may study new drugs or other ways of treating cancer, or they may look at new combinations of established treatments. Clinical trials progress in three stages:

Phase I studies the safety of a new treatment.

Phase II studies determine how effective a treatment is against a cancer.

Phase III studies, which usually involve many patients in different places, test the new treatment in comparison to the current standard treatment.

Where do clinical trials take place?

These trials take place in cancer centers, other major medical centers, community hospitals and clinics, and veterans' and military hospitals all over the country. Hundreds of clinical trails are carried out by large networks, called cooperative clinical groups, that are funded by the National Cancer Institute (NCI). The cancer specialists, or oncologists, who belong to these networks conduct joint studies simultaneously in many different places and pool their data.

What are the benefits of taking part in a trial?

One advantage is the possibility that a new treatment, diagnostic test, or preventive measure will turn out to be better than a more established procedure. In a Phase III, clinicaltrial patients either receive the most advanced and accepted treatment for the kind of cancer they have - known as the "standard" treatment, or a new treatment that has shown promise of being at least as beneficial as the standard treatment, if not better. People who take part in trials receive specialized care under a very detailed set of directions or protocol. Highly trained and experienced cancer specialists design, review, and approve each protocol. In addition, all clinical trial patients are carefully monitored during a trial and followed afterwards.

Many patients have said that they take part in trials also because it is an opportunity to contribute to new knowledge that may benefit others with cancer. Dr. Richard Schilsky, associate dean for clinical research at the University of Chicago and chairman of the Cancer and Leukemia Group B (CALGB) states "that patients who participate in trials have outcomes as good, if not better than, those who do not participate, even if they get standard therapy."

What are the risks?

Medical studies can carry unknown dangers and side effects, as well as hoped for benefits. The risks and benefits of each trial are explained in a document, called an informed consent form, that the patients discuss with their doctors or nurses before agreeing to participate. In addition health insurers and managed care providers do not always cover all the costs for care in a clinical trial.

What safeguards are there for patients?

Clinical trials are designed to provide for patients' safety and well-being, both medically and psychologically. The Institutional Review Board (IRB) of the hospital or facility administering the trial approves all clinical trials. During the trial, review committees make sure that the plan is being followed and participants are protected. Patients have the right to refuse or terminate participation in a clinical trial at any time.

How to find out about clinical trials:

1. Your doctor is an excellent source of information about clinical trials.

2. Call Gail Probst, RN, AOCN Coordinator of Cancer Services at Huntington Hospital, (631) 351-2568.

3. Call National Cancer Institute's Cancer Information Service (CIS) at 1-800-4CANCER or (1-800-422-6237) and ask for a customized search of the PDQ database, which provides information on current trials. Also ask for the pamphlet Taking Part in Clinical Trials, What Patients Need To Know.

4. Log on to the World Wide Web at: http://www.cancer.gov/clinicaltrials the NCI's website with information about cancer research studies.

5. Contact patient advocacy and voluntary organizations that may have information on specific cancers like National Association of Breast Cancer Organizations (www.nabco.org).