CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 115 enrolled
Drug / intervention
Radiotherapy +1 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01450449
NCT01450449Phase 3Completed

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

International Atomic Energy Agency·interventional·Posted Oct 12, 2011·Updated Mar 24, 2015

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

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 12, 2011
Enrollment StartFeb 1, 2009
Primary CompletionDec 1, 2013
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.7 years ago

Interventions

Radiotherapyradiation

25 Gy in 5 daily fractions over 1 week

Radiotherapyradiation

40 Gy in 15 daily fractions over 3 weeks