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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
115
25 Gy in 5 daily fractions over 1 week
40 Gy in 15 daily fractions over 3 weeks
Fundacion Escuela de Medicina Nuclear
Mendoza, Argentina
N.N. Alexandrov National Cancer Centre of Belarus
Minsk, Belarus
Irmandade de Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
Hospital "A.C. Camargo", Fundacao "Antonio Prudente"
São Paulo, Brazil
Wilson Roa Professional Corporation
Edmonton, Canada
Instituto de Radiomedicina (IRAM)
Santiago, Chile
Regionaalhailga
Tallinn, Estonia
High Technology Medical Center, University Clinic
Tbilisi, Georgia
Postgraduate Institute of Medical Education and Research (PGIMER)
Chandigarh, India
Cipto Magunkusumo General Hospital, University of Indonesia
Jakarta, Indonesia
...and 5 more locations
Overall Survival
The time from randomization to the time of death from any cause.
Time frame: 2.5 years
Progression-free survival
2.5 years including six months of follow-up after initial accrual.
Time frame: 2.5 years
Quality of Life
Quality of life will be assessed prior to study randomization and 4 weeks following completion of radiotherapy.
Time frame: 2.5 years
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