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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Douglas Kondziolka
Study Chair
University of Pittsburgh
United States: Federal Government
199/11858
NCT00004659
November 1994
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