Randomized Phase III Study of Conventional Versus Hypofractionated Radiotherapy Combined With Temozolomide in Elderly Glioblastoma Patients
In newly diagnosed glioblastoma patients aged 70 years or older who are suitable for concurrent temozolomide, the optimal dose of radiation therapy is controversial . The purpose of this study is to compare conventional radiotherapy of 60 Gy (6 weeks) versus hypofractionated radiotherapy of 40 Gy (3 weeks) in terms of overall survival as the primary endpoint along with progression-free survival, toxicity, quality of life, and prognostic biomarkers.
• newly diagnosed glioblastoma according to the 2021 World Health Organization classification
• interval of ≤4 weeks between pathological diagnosis and randomization
• aged 70 years or older
• gadolinium-enhanced MRI within 72 hours of surgery
• known o6-methylguanine-DNA-methyltransferase promoter methylation status
• Karnofsky performance score ≥60
• stable or decreasing dose of steroid (if necessary)
• no history of brain radiotherapy
• no history of any systemic chemotherapy
• adequate hematological, renal and hepatic functions for temozolomide
• able to start radiotherapy within 3 weeks from randomization