Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study
OBJECTIVES: I. Compare the efficacy of radiotherapy with or without temozolomide in terms of
overall survival in patients with newly diagnosed glioblastoma multiforme. II. Compare the
toxicity profiles of these regimens in these patients. III. Compare the progression free
survival of these patients treated with these regimens. IV. Compare the quality of life in
these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, age (under 50 vs 50 and over), WHO/ECOG performance status (0-1 vs 2),
and extent of surgical resection (biopsy only vs complete or incomplete resection). Patients
are randomized to one of two treatment arms. Arm I: Patients undergo radiotherapy 5 days a
week for 6 weeks. Arm II: Patients undergo radiotherapy as in arm I concurrently with oral
temozolomide daily for 6 weeks. Patients then receive adjuvant oral temozolomide alone on
days 1-5 every 28 days for 6 courses beginning 4 weeks after completion of radiotherapy.
Quality of life is assessed prior to the study, at week 4 during radiotherapy, at 4 weeks
after completion of radiotherapy, at the end of courses 3 and 6 of adjuvant chemotherapy
(arm II), and then every 3 months until disease progression. Patients are followed every 3
months until disease progression or death.
PROJECTED ACCRUAL: A total of 520 patients (260 per treatment arm) will be accrued for this
study within 3.5 years.
Primary Purpose: Treatment
Roger Stupp, MD
Centre Hospitalier Universitaire Vaudois
United States: Federal Government