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

CE6

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.

2007-11-14

2016-03-01

2016-08-10

Completed

Early phase I

562

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 562, 'type': 'ACTUAL'}}

2023-08-22