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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00482677
Other study ID # CE6
Secondary ID CAN-NCIC-CE6EORT
Status Completed
Phase Phase 3
First received
Last updated
Start date November 14, 2007
Est. completion date August 10, 2016

Study information

Verified date April 2020
Source Canadian Cancer Trials Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT00493207

Recruitment information / eligibility

Status Completed
Enrollment 562
Est. completion date August 10, 2016
Est. primary completion date March 1, 2016
Accepts healthy volunteers No
Gender All
Age group 65 Years to 120 Years
Eligibility DISEASE CHARACTERISTICS: - Histopathologically confirmed glioblastoma multiforme - Grade IV disease by WHO classification - Newly diagnosed disease - Initial diagnostic surgery or biopsy performed within the past 4 weeks - Not a candidate for standard radiotherapy (60Gy/30 fractions over 6 weeks) in combination with temozolomide PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Absolute granulocyte count = 1,500/mm³ - Platelet count = 100,000/mm³ - Creatinine = 1.5 times upper limit of normal (ULN) - Bilirubin = 1.5 times ULN - ALT and AST < 2.5 times ULN - No known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide - No history of other malignancies except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years - No serious active infection (e.g., wound infection requiring parenteral antibiotics) or other serious underlying medical conditions that would preclude study treatment - No other condition (e.g., psychological or geographical) that would preclude study compliance PRIOR CONCURRENT THERAPY: - No prior chemotherapy - No prior radiotherapy - No prior or concurrent investigational therapy - No concurrent surgical procedures for tumor debulking - No concurrent stereotactic boost radiotherapy - No other concurrent chemotherapy, immunotherapy, or biological therapy - No concurrent epoetin alfa - Concurrent corticosteroids allowed provided the patient has been on a stable or decreasing dose for at least 14 days

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.
Genetic:
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
Procedure:
quality-of-life assessment
prior to randomization until end of study
Radiation:
Radiation
Short course radiotherapy

Locations

Country Name City State
Canada Tom Baker Cancer Centre Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
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 CHUM - Hopital Notre-Dame Montreal Quebec
Canada McGill University - Dept. Oncology Montreal Quebec
Canada Atlantic Health Sciences Corporation Saint John New Brunswick
Canada Centre hospitalier universitaire de Sherbrooke Sherbrooke Quebec
Canada BCCA - Fraser Valley Cancer Centre Surrey British Columbia
Canada Odette Cancer Centre Toronto Ontario
Canada Univ. Health Network-Princess Margaret Hospital Toronto Ontario
Canada Centre hospitalier regional de Trois-Rivieres Trois-Rivieres Quebec
Canada BCCA - Vancouver Cancer Centre Vancouver British Columbia
Canada BCCA - Vancouver Island Cancer Centre Victoria British Columbia
Canada CancerCare Manitoba Winnipeg Manitoba
Germany Klinikum Der J.W. Goethe Universitaet Frankfurt
Germany Universitaetsklinikum Freiburg Freiburg
Germany Universitaetsklinikum Leipzig Leipzig
Germany Universitaetsklinikum Tuebingen Tuebingen
Japan Hiroshima University Hospital Hiroshima
Netherlands Maastro - Maastricht Radiation Oncology Maastricht

Sponsors (3)

Lead Sponsor Collaborator
Canadian Cancer Trials Group European Organisation for Research and Treatment of Cancer - EORTC, Trans Tasman Radiation Oncology Group

Countries where clinical trial is conducted

Canada,  Germany,  Japan,  Netherlands, 

References & Publications (1)

Perry JR, Laperriere N, O'Callaghan CJ, Brandes AA, Menten J, Phillips C, Fay M, Nishikawa R, Cairncross JG, Roa W, Osoba D, Rossiter JP, Sahgal A, Hirte H, Laigle-Donadey F, Franceschi E, Chinot O, Golfinopoulos V, Fariselli L, Wick A, Feuvret L, Back M, — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival Time from date of randomization to the date of death of any causes, or censored at last known alive date. 7 years
Secondary Progression-free Survival Time from date of randomization to the date of disease progression or death whichever came first, or censored at last disease assessment date. 7 years
Secondary Adverse Events Evaluated according to CTCAE V3.0 7 years
Secondary Methylation Status of the O6-methylguanine-DNA Methyltransferase Promoter Overall survival for patients by Methylation status of the O6-methylguanine-DNA methyltransferase promoter 7 years
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