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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450449
• Other study ID #: E33033
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2011
• Last updated: March 23, 2015
• Start date: February 2009
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: International Atomic Energy Agency
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Nations: International Atomic Energy Agency
• Study type: Interventional

Clinical Trial 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%).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: November 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Radiation:
• Radiotherapy
25 Gy in 5 daily fractions over 1 week
• Radiotherapy
40 Gy in 15 daily fractions over 3 weeks

Locations

Country	Name	City	State
Argentina	Fundacion Escuela de Medicina Nuclear	Mendoza
Belarus	N.N. Alexandrov National Cancer Centre of Belarus	Minsk
Brazil	Irmandade de Santa Casa de Misericordia de Porto Alegre	Porto Alegre
Brazil	Hospital "A.C. Camargo", Fundacao "Antonio Prudente"	Sao Paulo
Canada	Wilson Roa Professional Corporation	Edmonton
Chile	Instituto de Radiomedicina (IRAM)	Santiago
Estonia	Regionaalhailga	Tallinn
Georgia	High Technology Medical Center, University Clinic	Tbilisi
India	Postgraduate Institute of Medical Education and Research (PGIMER)	Chandigarh
Indonesia	Cipto Magunkusumo General Hospital, University of Indonesia	Jakarta
Ireland	ICORG The All Ireland Cooperative Oncology	Dublin
Poland	Marie Curie- Sklodowska Institute of Oncology	Warsaw
Thailand	Division of Therapeutic Radiology and Oncology, Faculty of Medicine, Chiang Mai University	Chiang Mai
Tunisia	Institut National de Cancer Salah Aziz, Ministere de la Sante Publique	Tunis
Turkey	Ege University Hospital	Izmir

Sponsors (15)

Lead Sponsor

Collaborator

International Atomic Energy Agency

Chiang Mai University, Dr Cipto Mangunkusumo General Hospital, Ege University, Fundación Escuela de Medicina Nuclear, High Technology Medical Center, Hospital A.C. Camargo, ICORG- All Ireland Cooperative Oncology Research Group, Institut National de Cancer Salah Azaiz, Instituto de Radiomedicina (IRAM), Irmandade Santa Casa de Misericórdia de Porto Alegre, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology, N.N. Alexandrov National Cancer Centre of Belarus, Postgraduate Institute of Medical Education and Research, Wilson Roa Professional Corporation

Countries where clinical trial is conducted

Argentina,  Belarus,  Brazil,  Canada,  Chile,  Estonia,  Georgia,  India,  Indonesia,  Ireland,  Poland,  Thailand,  Tunisia,  Turkey, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2004 Mar 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	The time from randomization to the time of death from any cause.	2.5 years	No
Secondary	Progression-free survival	2.5 years including six months of follow-up after initial accrual.	2.5 years	No
Secondary	Quality of Life	Quality of life will be assessed prior to study randomization and 4 weeks following completion of radiotherapy.	2.5 years	No