Trial Information

A Randomized Phase III Study of Temozolomide and Short-Course Radiation Versus Short-Course Radiation Alone In The Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients

OBJECTIVES:

Primary

- Compare overall survival rates in older patients with newly diagnosed glioblastoma
multiforme treated with short-course radiotherapy with or without temozolomide.

Secondary

- Compare progression-free survival of patients treated with these regimens.

- Compare the nature, severity, and frequency of adverse events in patients treated with
these regimens.

- Compare the quality of life of patient treated with these regimens.

- Determine the methylation status of the O6-methylguanine-DNA methyltransferase
promoter.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
center, age (65-70 years vs 71-75 years vs ≥ 76 years), ECOG performance status (0-1 vs 2),
and extent of resection at surgery (biopsy only vs complete or incomplete resection).
Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo radiotherapy once daily on days 1-5, 8-12, and 15-19 in the
absence of disease progression or unacceptable toxicity.

- Arm II: Patients undergo radiotherapy as in arm I and receive oral temozolomide once
daily on days 1-21.

Beginning 4 weeks after completion of radiotherapy and temozolomide, patients receive
adjuvant oral temozolomide once daily on days 1-5. Treatment with temozolomide alone repeats
every 28 days for up to 12 months in the absence of disease progression or unacceptable
toxicity.

Patients complete quality of life questionnaires at baseline and periodically during study
treatment.

Tissue samples are collected at baseline and analyzed for methylation status of the
O6-methylguanine-DNA methyltransferase promoter.

After completion of study treatment, patients are followed every 3 months.