The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.


PROTOCOL OUTLINE: This is a randomized study. Tumor size and number are confirmed prior to randomization. Patients are stratified by participating institution. Patients are randomly assigned to 1 of 2 treatment groups. One group is treated with fractionated whole-brain irradiation using megavoltage equipment. The second group receives stereotactic radiosurgery plus fractionated whole-brain radiotherapy. Stereotactic radiosurgery involves irradiation of all tumors to the margins on stereotactic computerized tomography or magnetic resonance imaging. Either treatment may be administered first; the second treatment begins within 1 month of the first. Concurrent anticonvulsants and steroids are allowed. Patients are followed for change in size and number of tumors at 1, 3, and 6 months; follow-up clinical exams are performed at least every 2 months.

Eligibility Criteria:

- Multiple newly diagnosed brain tumors - Histologic confirmation of carcinoma at primary or metastatic site - Tumors less than 25 mm mean diameter and more than 5 mm from optic chiasm - No more than 4 tumors on magnetic resonance imaging - Systemic disease controlled - Neurologic function preserved - Radiographic staging within 2 months of randomization required - Performance status: Karnofsky 70%-100%

Study Design: