Brain and Central Nervous System Tumors Clinical Trial
Official title:
Focal Fractionated Conformal Stereotactic Boost Following Conventional Radiotherapy of High Grade Gliomas: A Randomized Phase III Study
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an
effective treatment for patients with glioma. Stereotactic radiation therapy may be able to
deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet
known if standard radiation therapy is more effective when followed by stereotactic
radiation therapy.
PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation
therapy with or without stereotactic radiation therapy in treating patients who have glioma.
OBJECTIVES: I. Compare the effect of adjuvant conventional radiotherapy with or without
fractionated stereotactic boost radiotherapy on survival in patients with high grade glioma.
II. Compare the quality of life of these patients after these therapies.
OUTLINE: This is a randomized study. Patients are stratified according to WHO disease grade
(III vs IV), center, and age (under 40 vs 40 and over). Patients are randomized to undergo
stereotactic radiotherapy or no further treatment after conventional radiotherapy. Patients
undergo conventional radiotherapy once or twice a day for up to 6 weeks. Patients randomized
to receive additional treatment receive stereotactically guided conformal boost radiotherapy
for 4 days, within 4 weeks after completion of conventional radiotherapy. Quality of life is
assessed before radiotherapy, then at follow up visits. Patients are followed every 3 months
for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 605 patients will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Treatment
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