562
Participants
Start Date
November 14, 2007
Primary Completion Date
March 1, 2016
Study Completion Date
August 10, 2016
temozolomide
Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.
DNA methylation analysis
A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms
quality-of-life assessment
prior to randomization until end of study
Radiation
Short course radiotherapy
Maastro - Maastricht Radiation Oncology, Maastricht
Klinikum Der J.W. Goethe Universitaet, Frankfurt
Universitaetsklinikum Tuebingen, Tübingen
Universitaetsklinikum Freiburg, Freiburg im Breisgau
Tom Baker Cancer Centre, Calgary
Cross Cancer Institute, Edmonton
BCCA - Fraser Valley Cancer Centre, Surrey
BCCA - Vancouver Cancer Centre, Vancouver
BCCA - Vancouver Island Cancer Centre, Victoria
CancerCare Manitoba, Winnipeg
Atlantic Health Sciences Corporation, Saint John
QEII Health Sciences Centre, Halifax
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton
London Regional Cancer Program, London
Odette Cancer Centre, Toronto
Univ. Health Network-Princess Margaret Hospital, Toronto
CHUM - Hopital Notre-Dame, Montreal
McGill University - Dept. Oncology, Montreal
Centre hospitalier universitaire de Sherbrooke, Sherbrooke
Centre hospitalier regional de Trois-Rivieres, Trois-Rivières
Universitaetsklinikum Leipzig, Leipzig
Hiroshima University Hospital, Hiroshima
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Trans Tasman Radiation Oncology Group
OTHER
Canadian Cancer Trials Group
NETWORK