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

NCT ID: NCT01450449

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2014-11-30

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%).

Detailed Description

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)

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1 - Short Course Radiotherapy

Short Course

Group Type: EXPERIMENTAL

Radiotherapy

Intervention Type: RADIATION

25 Gy in 5 daily fractions over 1 week

Arm 2 - Standard Course Radiotherapy

Standard Course

Group Type: ACTIVE_COMPARATOR

Radiotherapy

Intervention Type: RADIATION

40 Gy in 15 daily fractions over 3 weeks

Interventions

Radiotherapy

25 Gy in 5 daily fractions over 1 week

Intervention Type: RADIATION

Radiotherapy

40 Gy in 15 daily fractions over 3 weeks

Intervention Type: RADIATION

Eligibility Criteria

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 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.

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Escuela de Medicina Nuclear

OTHER

Sponsor Role: collaborator

N.N. Alexandrov National Cancer Centre

OTHER_GOV

Sponsor Role: collaborator

Hospital A.C. Camargo

OTHER

Sponsor Role: collaborator

Irmandade Santa Casa de Misericórdia de Porto Alegre

OTHER

Sponsor Role: collaborator

Instituto de Radiomedicina (IRAM)

UNKNOWN

Sponsor Role: collaborator

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: collaborator

Dr Cipto Mangunkusumo General Hospital

OTHER

Sponsor Role: collaborator

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role: collaborator

Chiang Mai University

OTHER

Sponsor Role: collaborator

Salah Azaïz Cancer Institute

OTHER

Sponsor Role: collaborator

Wilson Roa Professional Corporation

UNKNOWN

Sponsor Role: collaborator

Cancer Trials Ireland

NETWORK

Sponsor Role: collaborator

Ege University

OTHER

Sponsor Role: collaborator

High Technology Medical Center

UNKNOWN

Sponsor Role: collaborator

International Atomic Energy Agency

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena Fidarova

Role: PRINCIPAL_INVESTIGATOR

International Atomic Energy Agency

Locations

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

ICORG The All Ireland Cooperative Oncology

Dublin, , Ireland

Marie Curie- Sklodowska Institute of Oncology

Warsaw, , Poland

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

Chiang Mai, , Thailand

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

Tunis, , Tunisia

Ege University Hospital

Izmir, , Turkey (Türkiye)

Countries

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

References

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.

Reference Type: BACKGROUND

PMID: 2851647 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8040031 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9212001 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10582674 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15051755 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26392096 (View on PubMed)

Other Identifiers

E33033

Identifier Type: -

Identifier Source: org_study_id