Brain and Central Nervous System Tumors Clinical Trial
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
Verified date | April 2020 |
Source | Canadian Cancer Trials Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Canadian Cancer Trials Group | European Organisation for Research and Treatment of Cancer - EORTC, Trans Tasman Radiation Oncology Group |
Canada, Germany, Japan, Netherlands,
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
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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