Standard Radiation Therapy, Higher-Dose Radiation Therapy, or Chemotherapy in Treating Older Patients With Glioblastoma Multiforme
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.
|Brain and Central Nervous System Tumors||Drug: temozolomide Radiation: hypofractionated radiation therapy Radiation: radiation therapy||Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Randomized Study of Normal-fractionated Radiotherapy Versus Hypofractionated Radiotherapy Versus Chemotherapy in Patients Over 60 Years With Malignant Glioma|
- Duration of survival
|Study Start Date:||July 2006|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients undergo standard radiotherapy 5 days a week for 6 weeks.
Radiation: radiation therapy
Patients undergo standard radiotherapy
Experimental: Arm II
Patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks.
Radiation: hypofractionated radiation therapy
Patients undergo hypofractionated radiotherapy
Experimental: Arm III
Patients receive oral temozolomide on days 1-5. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Compare the survival of patients over 60 with glioblastoma multiforme treated with standard radiotherapy vs hypofractionated radiotherapy vs chemotherapy.
- Compare the quality of life (QLQ-C30) of these patients.
- Compare the safety, tolerance, and toxicity of these regimens.
- Assess the pharmacoeconomic cost of these regimens.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients undergo standard radiotherapy 5 days a week for 6 weeks.
- Arm II: Patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks.
- Arm III: Patients receive oral temozolomide on days 1-5. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820963
|Centre Leon Berard|
|Lyon, France, 69373|
|OverallOfficial:||Didier Frappaz, MD||Centre Leon Berard|