NCT00006353

Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 575 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without temozolomide for glioblastoma multiforme. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.

Detailed description

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	temozolomide
RADIATION	radiation therapy

Timeline

• Start date: 2000-07-01
• Primary completion: 2002-03-01
• First posted: 2003-12-24
• Last updated: 2012-09-24

Locations

16 sites across 1 country: Canada