At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Radiotherapy for Glioblastoma Multiforme. Completed, enrolled 115 participants across 15 sites in 14 countries.
Detailed Summary
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%).
Study Details
Timeline
Interventions
25 Gy in 5 daily fractions over 1 week
40 Gy in 15 daily fractions over 3 weeks