NCT01450449

Short Course vs. Standard Course Radiotherapy in Elderly and/or Frail Patients With Glioblastoma Multiforme

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: International Atomic Energy Agency · Other Government
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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%).

Detailed description

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)

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
RADIATION	Radiotherapy	25 Gy in 5 daily fractions over 1 week
RADIATION	Radiotherapy	40 Gy in 15 daily fractions over 3 weeks

Timeline

• Start date: 2009-02-01
• Primary completion: 2013-12-01
• Completion: 2014-11-01
• First posted: 2011-10-12
• Last updated: 2015-03-24

Locations

15 sites across 14 countries: Argentina, Belarus, Brazil, Canada, Chile, Estonia, Georgia, India, Indonesia, Ireland, Poland, Thailand, Tunisia, Turkey (Türkiye)