Brain and Central Nervous System Tumors Clinical Trial
Official title:
A PHASE III TRIAL COMPARING THE USE OF RADIOSURGERY FOLLOWED BY CONVENTIONAL RADIOTHERAPY WITH BCNU TO CONVENTIONAL RADIOTHERAPY WITH BCNU FOR SUPRATENTORIAL GLIOBLASTOMA MULTIFORME
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Chemotherapy
uses different ways to stop tumor cells from dividing so they stop growing or die. Combining
radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy and
carmustine in treating patients who have supratentorial glioblastoma multiforme.
OBJECTIVES: I. Determine whether the use of radiosurgery (stereotactic external-beam
irradiation) prior to conventional radiotherapy with carmustine (BCNU) improves overall
survival compared to conventional radiotherapy plus BCNU alone in patients with
supratentorial glioblastoma multiforme. II. Determine and compare the frequency and severity
of toxicities associated with these regimens. III. Compare the effects of these two regimens
on neurologic function and quality of life.
OUTLINE: Randomized study. Arm I: Radiotherapy plus Single-Agent Chemotherapy. Tumor
irradiation using megavoltage equipment (at least 4 MV photons); plus Carmustine, BCNU,
NSC-409962. Arm II: Radiosurgery followed by Radiotherapy plus Single-Agent Chemotherapy.
Stereotactic tumor irradiation; followed by tumor irradiation as in Arm I; plus BCNU.
PROJECTED ACCRUAL: 200 patients will be entered over approximately 3 years.
;
Allocation: Randomized, Primary Purpose: Treatment
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