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Experimental Treatments for Cancer: The Clinical Trial

Clinical trials or protocols are the best way to test new treatments. In clinical trials doctors test new treatments (surgery, chemotherapy, biological response modifiers, and radiation therapy) scientifically. In some trials, all patients receive the new, experimental treatment, usually to learn the effects on the tumor and how patients react. If the results are promising, a second type of trial is conducted in which patients are randomly given either the best standard treatment for their disease or a new, experimental treatment. People with cancer take part in clinical trials for two reasons: the new treatments may help the people participating in the trial, or they may help future patients. The goal of a clinical trial is to determine whether the new, experimental treatment is better than the standard treatment.

You may want to try a new, exploratory treatment for your disease. This is understandable, especially if the standard treatments don't appear to be helping or cannot cure the cancer. The most important thing to remember when considering experimental treatments is that the accepted medical treatment for your cancer is the best scientifically tested treatment available. If you do try experimental treatments, you will be carefully monitored. Your doctor and nurse will explain what care you will need while you are participating in the trial.

Not everyone is eligible to participate in a clinical trial. Each trial is designed to test a specific treatment with a specific group of patients. Usually a trial will be limited to a certain type of cancer at a certain stage. Sometimes researchers also exclude certain patients, such as those who have other illnesses in addition to their cancer or who have already received a particular treatment. Your doctor will know what trials you will qualify for.

Before you consider participating in a trial, remember that a clinical trial attempts to answer a question that may or may not be important for your case. In general, trials have several choices or treatment "arms." One of the arms may be a standard form of treatment, while the others may be experimental. In either case no one knows which arm is better. In a multi- arm trial, one treatment is compared with another. You will be assigned to one arm by a computer, and you and your doctor agree to accept the assigned arm.

Clinical trials are carried out in cancer centers, community hospitals, and private oncology practices. The best way to become involved in a clinical trial is to talk to your doctor, who will know if clinical trials are available for your type of cancer. He or she may be participating in a clinical trial or will refer you to a center or hospital where a trial is being performed. You may call 1-800-4-CANCER to request information about a clinical trial, or write to the NCI for the booklet "What Are Clinical Trials All About?"

• Participating in a clinical trial does not mean that you are allowing your survival to be determined by a computer. All arms of a trial have been found to have some effect. No clinical trial is ever allowed in which it is known that one arm is worse than another. That would be unethical. The real question to be decided is which arm is better, given the fact that both arms seem to be effective.

• The use of biologic response modifiers (BRMs) is an example of how advances in cancer treatment are made through the clinical trial. Before BRMs can be approved as standard treatment, clinical trials must be conducted to compare them with standard chemotherapy and radiation therapy. When these trials show that BRMs are effective, this treatment will become standard for certain types of cancer.

• Clinical trials are organized by teams of doctors who belong to national "study groups." Doctors belong to these national groups in order to test new treatments on large groups of people. In this way, they can obtain information about better treatments more quickly than if doctors studied these treatments by themselves. The National Cancer Institute also organizes clinical trials.

To keep track of all of the standard and experimental treatments for cancer, the National Cancer Institute has set up a system called the Physician Data Query (PDQ). The PDQ contains information on standard treatments for cancer, plus information on more than 1,000 active clinical trials. If your doctor does not have computer access to the PDQ, the National Cancer Institute can explain other ways in which he or she can obtain PDQ information. You can obtain this information by calling 1-800-4-CANCER.

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