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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

Phase 3
50 Years
Open (Enrolling)
Glioblastoma Multiforme

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Trial Information

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

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)


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)

Inclusion Criteria:

- Histopathologically confirmed newly diagnosed glioblastoma multiforme (GBM, WHO grade
IV). The histological diagnosis must have been made locally after biopsy or
neurosurgical tumour resection.

- Initial surgery/biopsy at diagnosis performed < 6 weeks (42 days) prior to

- Patient's age is 50 years or older.

- Karnofsky performance status is 50% or higher.

- Patients may have received and continue to receive corticosteroids, but they have to
be on a stable or decreasing dose for at least 14 days prior to randomization.

- Patients must not have received prior chemotherapy or radiotherapy.

- Patient is able (i.e. sufficiently fluent) and willing to complete the quality of
life questionnaires in either English or any other language the questionnaire is
officially translated into. The baseline assessment (prior to start of radiotherapy)
must already have been completed. Inability (illiteracy, loss of sight, or other
equivalent reason) to complete the questionnaires will not make the patient
ineligible for the study. In centres where patients are not able to read or write,
proxy interviews will be conducted in-person or via telephone by the nurse at that
particular centre.

- Patient consent must be obtained according to local institutional policy.
It will be the responsibility of the local participating investigators to obtain
the necessary local clearance, and to indicate in writing to the IAEA Study
Coordinator that such clearance has been obtained, before the trial can commence
in that centre. A copy of the initial full board ERB approval and approved consent
form must be sent to the Project Officer at IAEA. The patient must sign the consent
form prior to randomization or registration.

- Patients must be accessible for treatment and follow-up. Investigators must assure
themselves the patients randomized on this trial will be available for complete
documentation of the treatment, adverse events, and follow-up.

- Protocol treatment is to begin within 2 weeks of patient randomization.

Exclusion Criteria:

- Patients with a history of other malignancies, except: adequately treated
non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other
solid tumours curatively treated with no evidence of disease for 3 or more years.

- Patients with a serious active infection or other serious underlying medical
conditions that would impair the ability of the patient to receive protocol treatment
or comply with protocol.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

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

Outcome Time Frame:

2.5 years

Safety Issue:


Principal Investigator

Elena Fidarova

Investigator Role:

Principal Investigator

Investigator Affiliation:

International Atomic Energy Agency


United Nations: International Atomic Energy Agency

Study ID:




Start Date:

February 2009

Completion Date:

Related Keywords:

  • Glioblastoma Multiforme
  • GBM, fractionation, short course, standard course
  • Glioblastoma