Standard Radiation Therapy, 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.

DISEASE CHARACTERISTICS:

• Histologically confirmed glioblastoma multiforme

• Grade 4 disease (WHO)

PATIENT CHARACTERISTICS:

• WHO performance status (PS) 0-2 (PS 3-4 allowed if secondary to a neurological physical handicap)
• Life expectancy ≥ 3 months
• ANC ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10 g/dL
• Bilirubin < 1.5 times upper limit of normal (ULN)
• Transaminases ≤ 3 times ULN
• Creatinine < 1.5 times ULN
• Able to tolerate the 3 treatment options
• No other malignancy within the past 5 years except for curatively treated basal cell or squamous cell carcinoma of the skin
• No acute or chronic severe illness that, in the investigator's opinion, contraindicates participation in the study

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy, radiotherapy, or immunotherapy
• Concurrent corticosteroids allowed provided patient is receiving the lowest dose necessary for optimal functioning