Glioblastoma Multiforme Clinical Trial
Official title:
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, Karnofsky Performance
Status and extent of the surgical resection.
This study will assess the effect of a one-week radiotherapy regimen in comparison with a
three-week radiotherapy regimen on the survival of elderly and/or frail patients with
glioblastoma multiforme (Frail: ≥>50 years old and with a KPS of 50% or less50%-70%; Elderly
and frail: ≥65 years and with a KPS of 50% - 70%; Elderly: ≥65 years and with a KPS of 80% -
100%).
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)
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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