RecruitingPhase 3NCT05439278

Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma

Randomized Phase III Study of Conventional Versus Hypofractionated Radiotherapy Combined With Temozolomide in Elderly Glioblastoma Patients

Sponsor

Severance Hospital

Enrollment

178 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Glioblastoma

Summary

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.

Eligibility

Min Age: 70 Years

Inclusion Criteria11

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

Exclusion Criteria9

patients with spinal leptomeningeal carcinomatosis
history of cancer other than the followings:
carcinoma in situ of the cervix
completely excised non-melanoma skin cancer
cancers without any evidence of residual disease for 5 years or longer
patients with serious active infection or other serious underlying medical conditions
patients with psychological issues that cannot comply to the protocol
patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide
patients who are currently participating in other clinical trials