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Clinical Trials

Overview

Clinical trials search for better ways to treat children with this disease. Many people and organizations are involved in developing a clinical trial, and every clinical trial is reviewed many times by experts before being opened at treatment centers.

There are two general types of clinical trials:

1. Therapeutic clinical trials are used to evaluate new treatments. These studies are classified as three different types or phases.
   • Phase III studies, compare the new treatment with the current standard therapy.
     • Usually involve a larger number of patients at many hospitals in the United States or across the world.
     • Most patients who have just been diagnosed with a kidney tumor are treated on a phase III trial.
     • Benefits: Trial offers the most up-to-date treatments with the best-known results for improvement or cure of kidney tumors.
     • Potential risks: It is not known if the new treatment will be better than current standard treatment. Sometimes new side effects are revealed with the new treatment.
   • Phase II studies, investigate the safety and effectiveness of the treatment.
     • Trial is offered to patients who have not improved with other available treatments.
     • Benefits: A few patients may respond and show definite improvement of their kidney tumor.
     • Potential Risks: Benefits of the treatment are not known.
   • Phase I studies evaluate what dose is safe and how a new drug should be given
     • Trials only offered to patients whose kidney tumor has not improved with other less experimental treatments and they take place at only very few locations
     • Potential Benefits: A few patients may respond to the new treatment (usually less than 1 in 20).
     • Potential Risks: Side effects of the new treatment may be worse than expected.
2. Non-therapeutic trials are those that involve other aspects of kidney tumors such as:
   • Epidemiology (incidence and causes)
   • Biology studies ( banking of blood and tumor tissue)
   • Late Effects (long-term complications of treatment)