Brain and Central Nervous System Tumors Clinical Trial
Official title:
Randomized Study of Normal-fractionated Radiotherapy Versus Hypofractionated Radiotherapy Versus Chemotherapy in Patients Over 60 Years With Malignant Glioma
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation
therapy in higher doses over a shorter period of time may kill more tumor cells and have
fewer side effects. Drugs used in chemotherapy, such as temozolomide, work in different ways
to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. It is not yet known whether standard radiation therapy, higher-dose radiation
therapy, or chemotherapy is more effective in treating older patients with glioblastoma
multiforme.
PURPOSE: This randomized phase III trial is studying standard radiation therapy to see how
well it works compared with higher-dose radiation therapy or chemotherapy in treating older
patients with glioblastoma multiforme.
OBJECTIVES:
Primary
- Compare the survival of patients over 60 with glioblastoma multiforme treated with
standard radiotherapy vs hypofractionated radiotherapy vs chemotherapy.
Secondary
- Compare the quality of life (QLQ-C30) of these patients.
- Compare the safety, tolerance, and toxicity of these regimens.
- Assess the pharmacoeconomic cost of these regimens.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients undergo standard radiotherapy 5 days a week for 6 weeks.
- Arm II: Patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks.
- Arm III: Patients receive oral temozolomide on days 1-5. Treatment repeats every 4
weeks for up to 6 courses in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed periodically.
;
Allocation: Randomized, Primary Purpose: Treatment
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