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

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%).

Conditions

• Glioblastoma Multiforme

Interventions

RADIATION

Radiotherapy

25 Gy in 5 daily fractions over 1 week

RADIATION

Radiotherapy

40 Gy in 15 daily fractions over 3 weeks

Sponsors & Collaborators

• Fundación Escuela de Medicina Nuclear

  collaborator OTHER

• N.N. Alexandrov National Cancer Centre

  collaborator OTHER_GOV

• Hospital A.C. Camargo

  collaborator OTHER

• Irmandade Santa Casa de Misericórdia de Porto Alegre

  collaborator OTHER

• Instituto de Radiomedicina (IRAM)

  collaborator UNKNOWN

• Post Graduate Institute of Medical Education and Research, Chandigarh

  collaborator OTHER

• Dr Cipto Mangunkusumo General Hospital

  collaborator OTHER

• Maria Sklodowska-Curie National Research Institute of Oncology

  collaborator OTHER

• Chiang Mai University

  collaborator OTHER

• Salah Azaïz Cancer Institute

  collaborator OTHER

• Wilson Roa Professional Corporation

  collaborator UNKNOWN

• Cancer Trials Ireland

  collaborator NETWORK

• Ege University

  collaborator OTHER

• High Technology Medical Center

  collaborator UNKNOWN

• International Atomic Energy Agency

  lead OTHER_GOV

Principal Investigators

• Elena Fidarova · International Atomic Energy Agency

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-02-28

Primary Completion

2013-12-31

Completion

2014-11-30

Countries

• Argentina
• Belarus
• Brazil
• Canada
• Chile
• Estonia
• Georgia
• India
• Indonesia
• Ireland
• Poland
• Thailand
• Tunisia
• Turkey (Türkiye)

Study Locations