Neoplasms

All Conditions

Rare Diseases

Glioblastoma

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Glioma

Neoplasms, Neuroepithelial

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Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Radiotherapy

Elena Fidarova

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)

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

The time from randomization to the time of death from any cause.

2.5 years including six months of follow-up after initial accrual.

Quality of life will be assessed prior to study randomization and 4 weeks following completion of radiotherapy.

Fundación Escuela de Medicina Nuclear

N.N. Alexandrov National Cancer Centre of Belarus

Hospital A.C. Camargo

Irmandade Santa Casa de Misericórdia de Porto Alegre

Instituto de Radiomedicina (IRAM)

Post Graduate Institute of Medical Education and Research, Chandigarh

Dr Cipto Mangunkusumo General Hospital

Maria Sklodowska-Curie National Research Institute of Oncology

Chiang Mai University

Salah Azaïz Cancer Institute

Wilson Roa Professional Corporation

Cancer Trials Ireland

Ege University

High Technology Medical Center

International Atomic Energy Agency

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Short Course vs. Standard Course Radiotherapy in Elderly and/or Frail Patients With Glioblastoma Multiforme	NCT01450449	Glioblastoma Mu...	Radiotherapy Radiotherapy	50 Years -	International Atomic Energy Agency
Short Course vs. Standard Course Radiotherapy in Elderly and/or Frail Patients With Glioblastoma Multiforme	NCT01450449	Glioblastoma Mu...	Radiotherapy Radiotherapy	50 Years -	International Atomic Energy Agency

Spots Global Cancer Trial Database for gbm, fractionation, short course, standard course