Spots Global Cancer Trial Database for Short Course vs. Standard Course Radiotherapy in Elderly and/or Frail Patients With Glioblastoma Multiforme
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Trial Identification
Brief Title: Short Course vs. Standard Course Radiotherapy in Elderly and/or Frail Patients With Glioblastoma Multiforme
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
Study ID: NCT01450449
Conditions
Study Description
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)
Eligibility
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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", Sao 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
Contact Details
Name: Elena Fidarova
Affiliation: International Atomic Energy Agency
Role: PRINCIPAL_INVESTIGATOR
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