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Spots Global Cancer Trial Database for Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 65 Years

Eligible Ages: OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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