A Randomized Phase III Study of Short Course (One-week) Radiation Therapy Versus Standard Course (Three-week) Radiation Therapy in Elderly and/or Frail Patients With Newly Diagnosed Glioblastoma Multiforme
This is a multi-centre prospective, non-inferiority trial. Patients will be
randomized to two treatment groups in a 1:1 ratio and will be stratified by:
- Age (<65 and ≥65 years old)
- Karnofsky Performance Status (≤70 and > 7050 or higher)
- Extent of the resection at surgery (biopsy only versus complete/near total and gross
total or incomplete /partial resection)
Randomization:
Patients will be randomized to receive one of the two following treatments:
Arm 1:
- Short Radiotherapy
- 25 Gy/5 fractions
- 1 week (5 fractions per week)
Arm 2:
- Regular Radiotherapy
- 40 Gy/15 fractions
- 3 weeks (5 fractions per week)
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival
The time from randomization to the time of death from any cause.
2.5 years
No
Elena Fidarova
Principal Investigator
International Atomic Energy Agency
United Nations: International Atomic Energy Agency
E33033
NCT01450449
February 2009
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