Radiation Therapy or Temozolomide in Treating Patients With Gliomas

DISEASE CHARACTERISTICS:

• Histologically confirmed low-grade glioma, including any of the following types:

  • Astrocytoma (gemistocytic, fibrillary, or protoplasmatic)
  • Oligoastrocytoma
  • Oligodendroglioma
• WHO grade II disease
• Supratentorial tumor location only
• RTOG neurological function 0-3
• Not a candidate for surgical treatment alone

• Requires treatment, as determined by ≥ 1 of the following criteria:

  • Age ≥ 40 years
  • Radiologically-proven progressive lesion
  • New or worsening neurological symptoms other than seizures only (e.g., focal deficits, signs of increased intracranial pressure, or mental deficits)

  • Intractable seizures, defined by both of the following criteria:

    • Experiences persistent seizures that interfere with everyday life activities except driving a car
    • Failed 3 anti-epileptic drug regimens, including ≥ 1 combination regimen
• Tumor material (paraffin-embedded) or histopathologic slides available

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• No chronic hepatitis B or C infection
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST or ALT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 6 months after completion of study treatment
• No known HIV positivity
• No other serious medical condition
• No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer
• No psychological, familial, sociological, or geographical condition that would preclude study participation
• No medical condition that would preclude receiving oral medication (e.g., frequent vomiting or partial bowel obstruction)

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent growth factors for elevating absolute neutrophil counts for the purpose of temozolomide administration
• No concurrent epoetin alfa
• No concurrent immunotherapy or biologic therapy

Chemotherapy

• No prior chemotherapy
• No other concurrent chemotherapy, including adjuvant chemotherapy for patients randomized to undergo radiotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to the brain
• No concurrent integrated boost with intensity-modulated radiotherapy

Surgery

• Recovered from prior surgery
• No concurrent surgical tumor debulking

Other

• No prior randomization to this study
• No other concurrent investigational drugs

• No concurrent regular use of agents known to be radiosensitizers or radioprotectors (e.g., cyclooxygenase-2 inhibitors, thalidomide, or amifostine) during study radiotherapy

  • Occasional use of nonsteroidal anti-inflammatory drugs for pain allowed