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Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Study Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without temozolomide for glioblastoma multiforme. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed glioblastoma multiforme by biopsy or surgical resection Grade IV disease Initial diagnosis no greater than 6 weeks prior to study.PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT less than 2.5 times ULN Alkaline phosphatase less than 2.5 times ULN No chronic hepatitis B or C Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known HIV infection No medical condition that would interfere with oral medication intake (e.g., frequent vomiting or partial bowel obstruction) No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer No serious medical, psychological, familial, sociological, or geographical condition that would preclude study.PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa No concurrent biologic therapy No concurrent immunotherapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: At least 14 days of prior corticosteroids at a stable dose required Concurrent corticosteroids allowed Radiotherapy: No prior radiotherapy No concurrent stereotactic boost radiotherapy Surgery: See Disease Characteristics No concurrent surgery for tumor debulking Other: No other concurrent investigational drugs

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00006353
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

European Organisation for Research and Treatment of Cancer - EORTC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Roger Stupp, MDVolker G. Budach, MD, PhDJ. Gregory Cairncross, MD
Principal Investigator Affiliation Centre Hospitalier Universitaire VaudoisCharite University, Berlin, GermanyLondon Health Sciences Centre
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors
Additional Details

OBJECTIVES:

  • I. Compare the efficacy of radiotherapy with or without temozolomide in terms of overall survival in patients with newly diagnosed glioblastoma multiforme.
  • II. Compare the toxicity profiles of these regimens in these patients.
  • III. Compare the progression free survival of these patients treated with these regimens.
  • IV. Compare the quality of life in these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (under 50 vs.#46;50 and over), WHO/ECOG performance status (0-1 vs.#46; 2), and extent of surgical resection (biopsy only vs.#46;complete or incomplete resection). Patients are randomized to one of two treatment arms. Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks. Arm II: Patients undergo radiotherapy as in arm I concurrently with oral temozolomide daily for 6 weeks. Patients then receive adjuvant oral temozolomide alone on days 1-5 every 28 days for 6 courses beginning 4 weeks after completion of radiotherapy. Quality of life is assessed prior to the study, at week 4 during radiotherapy, at 4 weeks after completion of radiotherapy, at the end of courses 3 and 6 of adjuvant chemotherapy (arm II), and then every 3 months until disease progression. Patients are followed every 3 months until disease progression or death. PROJECTED ACCRUAL: A total of 520 patients (260 per treatment arm) will be accrued for this study within 3.5 years.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada

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Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2

Cross Cancer Institute, Edmonton, Alberta, Canada

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Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2

Surrey, British Columbia, Canada

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British Columbia Cancer Agency - Fraser Valley Cancer Centre

Surrey, British Columbia, V3V 1Z2

British Columbia Cancer Agency, Vancouver, British Columbia, Canada

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British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6

Victoria, British Columbia, Canada

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British Columbia Cancer Agency - Vancouver Island Cancer Centre

Victoria, British Columbia, V8R 6V5

CancerCare Manitoba, Winnipeg, Manitoba, Canada

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CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9

Doctor Leon Richard Oncology Centre, Moncton, New Brunswick, Canada

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Doctor Leon Richard Oncology Centre

Moncton, New Brunswick, E1C 8X3

Saint John Regional Hospital, Saint John, New Brunswick, Canada

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Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2

St. Johns, Newfoundland and Labrador, Canada

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Newfoundland Cancer Treatment and Research Foundation

St. Johns, Newfoundland and Labrador, A1B 3V6

Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada

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Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7

London, Ontario, Canada

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Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6

Ottawa, Ontario, Canada

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Ottawa Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 1C4

Toronto, Ontario, Canada

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Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5

Princess Margaret Hospital, Toronto, Ontario, Canada

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Princess Margaret Hospital

Toronto, Ontario, M5G 2M9

Windsor, Ontario, Canada

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Cancer Care Ontario - Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3

Montreal, Quebec, Canada

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Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2L-4M1