Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- Genetic: DNA methylation analysisProcedure: quality-of-life assessmentRadiation: Radiation
- Registration Number
- NCT00482677
- Lead Sponsor
- Canadian Cancer Trials Group
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether radiation therapy and temozolomide are more effective than radiation therapy alone in treating glioblastoma multiforme.
PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared with radiation therapy alone in treating patients with newly diagnosed glioblastoma multiforme.
- Detailed Description
OBJECTIVES:
Primary
* Compare overall survival rates in older patients with newly diagnosed glioblastoma multiforme treated with short-course radiotherapy with or without temozolomide.
Secondary
* Compare progression-free survival of patients treated with these regimens.
* Compare the nature, severity, and frequency of adverse events in patients treated with these regimens.
* Compare the quality of life of patient treated with these regimens.
* Determine the methylation status of the O6-methylguanine-DNA methyltransferase promoter.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to center, age (65-70 years vs 71-75 years vs ≥ 76 years), ECOG performance status (0-1 vs 2), and extent of resection at surgery (biopsy only vs complete or incomplete resection). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo radiotherapy once daily on days 1-5, 8-12, and 15-19 in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily on days 1-25.
Beginning 4 weeks after completion of radiotherapy and temozolomide, patients receive adjuvant oral temozolomide once daily on days 1-5. Treatment with temozolomide alone repeats every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Patients complete quality of life questionnaires at baseline and periodically during study treatment.
Tissue samples are collected at baseline and analyzed for methylation status of the O6-methylguanine-DNA methyltransferase promoter.
After completion of study treatment, patients are followed every 3 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 562
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radiation quality-of-life assessment Short course radiation alone Temozolomide quality-of-life assessment Temozolomide and short course radiation Radiation DNA methylation analysis Short course radiation alone Temozolomide DNA methylation analysis Temozolomide and short course radiation Radiation Radiation Short course radiation alone Temozolomide temozolomide Temozolomide and short course radiation
- Primary Outcome Measures
Name Time Method Overall Survival 7 years Time from date of randomization to the date of death of any causes, or censored at last known alive date.
- Secondary Outcome Measures
Name Time Method Progression-free Survival 7 years Time from date of randomization to the date of disease progression or death whichever came first, or censored at last disease assessment date.
Adverse Events 7 years Evaluated according to CTCAE V3.0
Methylation Status of the O6-methylguanine-DNA Methyltransferase Promoter 7 years Overall survival for patients by Methylation status of the O6-methylguanine-DNA methyltransferase promoter
Trial Locations
- Locations (22)
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
CHUM - Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Universitaetsklinikum Freiburg
🇩🇪Freiburg, Germany
McGill University - Dept. Oncology
🇨🇦Montreal, Quebec, Canada
Odette Cancer Centre
🇨🇦Toronto, Ontario, Canada
Klinikum Der J.W. Goethe Universitaet
🇩🇪Frankfurt, Germany
BCCA - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Atlantic Health Sciences Corporation
🇨🇦Saint John, New Brunswick, Canada
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
QEII Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Univ. Health Network-Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Centre hospitalier regional de Trois-Rivieres
🇨🇦Trois-Rivieres, Quebec, Canada
Maastro - Maastricht Radiation Oncology
🇳🇱Maastricht, Netherlands
BCCA - Vancouver Island Cancer Centre
🇨🇦Victoria, British Columbia, Canada
Centre hospitalier universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada