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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Fundación Escuela de Medicina Nuclear
N.N. Alexandrov National Cancer Centre of Belarus
Hospital A.C. Camargo
Irmandade Santa Casa de Misericórdia de Porto Alegre
Instituto de Radiomedicina (IRAM)
Postgraduate Institute of Medical Education and Research
Dr Cipto Mangunkusumo General Hospital
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Chiang Mai University
Institut National de Cancer Salah Azaiz
Wilson Roa Professional Corporation
ICORG- All Ireland Cooperative Oncology Research Group
Ege University
High Technology Medical Center
Information provided by (Responsible Party):
International Atomic Energy Agency
ClinicalTrials.gov Identifier:
NCT01450449
First received: October 10, 2011
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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%).


Condition Intervention Phase
Glioblastoma Multiforme
Radiation: Radiotherapy
Phase 3

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

Resource links provided by NLM:


Further study details as provided by International Atomic Energy Agency:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    The time from randomization to the time of death from any cause.


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    2.5 years including six months of follow-up after initial accrual.

  • Quality of Life [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    Quality of life will be assessed prior to study randomization and 4 weeks following completion of radiotherapy.


Estimated Enrollment: 159
Study Start Date: February 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 - Short Course Radiotherapy
Short Course
Radiation: Radiotherapy
25 Gy in 5 daily fractions over 1 week
Active Comparator: Arm 2 - Standard Course Radiotherapy
Standard Course
Radiation: Radiotherapy
40 Gy in 15 daily fractions over 3 weeks

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)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450449

Locations
Argentina
Fundacion Escuela de Medicina Nuclear
Mendoza, Argentina, 5500
Belarus
N.N. Alexandrov National Cancer Centre of Belarus
Minsk, Belarus, 223040
Brazil
Irmandade de Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil, 90050-70
Hospital "A.C. Camargo", Fundacao "Antonio Prudente"
Sao Paulo, Brazil, 01509-010
Canada
Wilson Roa Professional Corporation
Edmonton, Canada, Alberta T6R 2A9
Chile
Instituto de Radiomedicina (IRAM)
Santiago, Chile, 6671407
Estonia
Regionaalhailga
Tallinn, Estonia
Georgia
High Technology Medical Center, University Clinic
Tbilisi, Georgia, 0144
India
Postgraduate Institute of Medical Education and Research (PGIMER)
Chandigarh, India, 160 012
Indonesia
Cipto Magunkusumo General Hospital, University of Indonesia
Jakarta, Indonesia, 10430
Ireland
ICORG The All Ireland Cooperative Oncology
Dublin, Ireland, 2
Poland
Marie Curie- Sklodowska Institute of Oncology
Warsaw, Poland, 02-781
Thailand
Division of Therapeutic Radiology and Oncology, Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand, 50002
Tunisia
Institut National de Cancer Salah Aziz, Ministere de la Sante Publique
Tunis, Tunisia, 1006
Turkey
Ege University Hospital
Izmir, Turkey
Sponsors and Collaborators
International Atomic Energy Agency
Fundación Escuela de Medicina Nuclear
N.N. Alexandrov National Cancer Centre of Belarus
Hospital A.C. Camargo
Irmandade Santa Casa de Misericórdia de Porto Alegre
Instituto de Radiomedicina (IRAM)
Postgraduate Institute of Medical Education and Research
Dr Cipto Mangunkusumo General Hospital
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Chiang Mai University
Institut National de Cancer Salah Azaiz
Wilson Roa Professional Corporation
ICORG- All Ireland Cooperative Oncology Research Group
Ege University
High Technology Medical Center
Investigators
Principal Investigator: Elena Fidarova International Atomic Energy Agency
  More Information

Additional Information:
Publications:
Responsible Party: International Atomic Energy Agency
ClinicalTrials.gov Identifier: NCT01450449     History of Changes
Other Study ID Numbers: E33033
Study First Received: October 10, 2011
Last Updated: March 5, 2014
Health Authority: United Nations: International Atomic Energy Agency

Keywords provided by International Atomic Energy Agency:
GBM, fractionation, short course, standard course

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 24, 2014