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 - temozolomide chemo-irradiation in elderly glioblastoma patients

European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 45 人开始时间: 待定最近更新: 2024年5月6日

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•- Histopathologically confirmed newly diagnosed glioblastoma multiforme (GBM, WHO grade IV).
•- The histological diagnosis must have been made after biopsy or neurosurgical tumour resection.
•- Initial surgery/biopsy at diagnosis performed < 4 weeks (28 days) prior to randomization.
•- Patient*s age is > 65 years.
•- Patient is not deemed suitable by the treating physician to receive the standard radiotherapy regimen
•- (60Gy/30 fractions over 6 weeks) in combination with temozolomide.
•- ECOG performance status of 0, 1 or 2
•- Patient may have received and continue to receive corticosteroids, but s/he have to be on a stable or decreasing dose for at least 14 days prior to randomization.
•- Patient has not received prior chemotherapy or radiotherapy.
•- Adequate hematological, renal and hepatic functions within 14 days prior to randomization
•- Patients must be accessible for treatment and follow-up
•- Informed consent

•- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for > 5 years.
•- Patients with a serious active infection (such as a wound infection requiring parenteral antibiotics) at the time of randomization or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment.
•- Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.
•- Patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide.
•- Patients who have had treatment with any investigational cancer drug prior to randomization.

发起方

European Organisation for Research in Treatment of Cancer (EORTC)