Standard Radiation Therapy, Higher-Dose Radiation Therapy, or Chemotherapy in Treating Older Patients With Glioblastoma Multiforme

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Leon Berard
• Treatments: Temozolomide

Criteria

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