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Studies of promising new or experimental treatments are known as clinical trials. A clinical trial is only done when there is some reason to believe that the treatment being studied may be of value to the patient. There are three phases of clinical trials (phase I, II, III) in which a treatment is studied before the treatment is eligible for approval by the FDA (Food and Drug Administration).

The purpose of a Phase I study is to find the best way to give a new treatment and how much of it can be given safely. Physicians watch patients carefully for any harmful side effects. An experimental treatment has typically been well tested in laboratory and animal studies, but the side effects in patients are not completely predictable.

Phase II trials determine the effectiveness of a research treatment after safety has been evaluated in a Phase I trial. Patients are closely observed for an anticancer effect by careful evaluation of primary or metastatic cancer sites present at the beginning of the trial. In addition to monitoring patients for response, any side effects are carefully recorded and assessed.

Phase III trials require entry of large numbers of patients. Some trials enroll thousands of patients. One of the groups may receive standard (the most accepted) treatment, so the effectiveness of the new treatment can be directly compared to what is already used. All patients in Phase III trials are monitored closely for side effects, and treatment is discontinued if the side effects are too severe or if a patient chooses to stop treatment.