NCT01450449

Brief 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%).

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_3

Geographic Reach
13 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

4.8 years

First QC Date

October 10, 2011

Last Update Submit

March 23, 2015

Conditions

Glioblastoma Multiforme

Keywords

GBM, fractionation, short course, standard course

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

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

    2.5 years

Secondary Outcomes (2)

  • Progression-free survival

    2.5 years

  • Quality of Life

    2.5 years

Study Arms (2)

Arm 1 - Short Course Radiotherapy

EXPERIMENTAL

Short Course

Radiation: Radiotherapy

Arm 2 - Standard Course Radiotherapy

ACTIVE COMPARATOR

Standard Course

Radiation: Radiotherapy

Interventions

RadiotherapyRADIATION

25 Gy in 5 daily fractions over 1 week

Arm 1 - Short Course Radiotherapy

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 randomization.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Fundacion Escuela de Medicina Nuclear

Mendoza, 5500, Argentina

Location

N.N. Alexandrov National Cancer Centre of Belarus

Minsk, 223040, Belarus

Location

Irmandade de Santa Casa de Misericordia de Porto Alegre

Porto Alegre, 90050-70, Brazil

Location

Hospital "A.C. Camargo", Fundacao "Antonio Prudente"

São Paulo, 01509-010, Brazil

Location

Wilson Roa Professional Corporation

Edmonton, Alberta T6R 2A9, Canada

Location

Instituto de Radiomedicina (IRAM)

Santiago, 6671407, Chile

Location

Regionaalhailga

Tallinn, Estonia

Location

High Technology Medical Center, University Clinic

Tbilisi, 0144, Georgia

Location

Postgraduate Institute of Medical Education and Research (PGIMER)

Chandigarh, 160 012, India

Location

Cipto Magunkusumo General Hospital, University of Indonesia

Jakarta, 10430, Indonesia

Location

ICORG The All Ireland Cooperative Oncology

Dublin, 2, Ireland

Location

Marie Curie- Sklodowska Institute of Oncology

Warsaw, 02-781, Poland

Location

Division of Therapeutic Radiology and Oncology, Faculty of Medicine, Chiang Mai University

Chiang Mai, 50002, Thailand

Location

Institut National de Cancer Salah Aziz, Ministere de la Sante Publique

Tunis, 1006, Tunisia

Location

Ege University Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (6)

  • Newall J, Ransohoff J, Kaplan B. Glioblastoma in the older patient: how long a course of radiotherapy is necessary? J Neurooncol. 1988 Dec;6(4):325-7. doi: 10.1007/BF00177427.

    PMID: 2851647BACKGROUND

  • Bauman GS, Gaspar LE, Fisher BJ, Halperin EC, Macdonald DR, Cairncross JG. A prospective study of short-course radiotherapy in poor prognosis glioblastoma multiforme. Int J Radiat Oncol Biol Phys. 1994 Jul 1;29(4):835-9. doi: 10.1016/0360-3016(94)90573-8.

    PMID: 8040031BACKGROUND

  • Kleinberg L, Slick T, Enger C, Grossman S, Brem H, Wharam MD Jr. Short course radiotherapy is an appropriate option for most malignant glioma patients. Int J Radiat Oncol Biol Phys. 1997 Apr 1;38(1):31-6. doi: 10.1016/s0360-3016(97)00222-8.

    PMID: 9212001BACKGROUND

  • Jeremic B, Shibamoto Y, Grujicic D, Milicic B, Stojanovic M, Nikolic N, Dagovic A, Aleksandrovic J. Short-course radiotherapy in elderly and frail patients with glioblastoma multiforme. A phase II study. J Neurooncol. 1999 Aug;44(1):85-90. doi: 10.1023/a:1006356021734.

    PMID: 10582674BACKGROUND

  • Roa W, Brasher PM, Bauman G, Anthes M, Bruera E, Chan A, Fisher B, Fulton D, Gulavita S, Hao C, Husain S, Murtha A, Petruk K, Stewart D, Tai P, Urtasun R, Cairncross JG, Forsyth P. Abbreviated course of radiation therapy in older patients with glioblastoma multiforme: a prospective randomized clinical trial. J Clin Oncol. 2004 May 1;22(9):1583-8. doi: 10.1200/JCO.2004.06.082. Epub 2004 Mar 29.

    PMID: 15051755BACKGROUND

  • Roa W, Kepka L, Kumar N, Sinaika V, Matiello J, Lomidze D, Hentati D, Guedes de Castro D, Dyttus-Cebulok K, Drodge S, Ghosh S, Jeremic B, Rosenblatt E, Fidarova E. International Atomic Energy Agency Randomized Phase III Study of Radiation Therapy in Elderly and/or Frail Patients With Newly Diagnosed Glioblastoma Multiforme. J Clin Oncol. 2015 Dec 10;33(35):4145-50. doi: 10.1200/JCO.2015.62.6606. Epub 2015 Sep 21.

    PMID: 26392096DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Elena Fidarova

    International Atomic Energy Agency

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2011

First Posted

October 12, 2011

Study Start

February 1, 2009

Primary Completion

December 1, 2013

Study Completion

November 1, 2014

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

BR(2)ID(1)IE(1)TU(1)TH(1)IN(1)GE(1)PL(1)CL(1)ES(1)CA(1)BE(1)AR(1)