The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme
Official Title: A Randomized Phase III Study of Temozolomide and Short-Course Radiation Versus Short-Course Radiation Alone In The Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients
Study ID: NCT00482677
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.
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BCCA - Fraser Valley Cancer Centre, Surrey, British Columbia, Canada
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
BCCA - Vancouver Island Cancer Centre, Victoria, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Atlantic Health Sciences Corporation, Saint John, New Brunswick, Canada
QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Odette Cancer Centre, Toronto, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
CHUM - Hopital Notre-Dame, Montreal, Quebec, Canada
McGill University - Dept. Oncology, Montreal, Quebec, Canada
Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
Centre hospitalier regional de Trois-Rivieres, Trois-Rivieres, Quebec, Canada
Klinikum Der J.W. Goethe Universitaet, Frankfurt, , Germany
Universitaetsklinikum Freiburg, Freiburg, , Germany
Universitaetsklinikum Leipzig, Leipzig, , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
Hiroshima University Hospital, Hiroshima, , Japan
Maastro - Maastricht Radiation Oncology, Maastricht, , Netherlands
Name: Normand Laperriere, MD, FRCPC
Affiliation: Princess Margaret Hospital, Canada
Role: STUDY_CHAIR
Name: James R. Perry, MD, FRCPC
Affiliation: Toronto Sunnybrook Regional Cancer Centre
Role: STUDY_CHAIR
Name: Alba A. Brandes, MD
Affiliation: Ospedale Bellaria
Role: STUDY_CHAIR
Name: Johan Menten, MD, PhD
Affiliation: University Hospital, Gasthuisberg
Role: STUDY_CHAIR