NCT05439278

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: Severance Hospital · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
RADIATION	Hypofractionated radiotherapy	40.05 Gy in 15 fractions (daily treatment, 5 per week)
RADIATION	Conventional radiotherapy	60 Gy in 30 fractions (daily treatment, 5 per week)
DRUG	Temozolomide	concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)

Timeline

• Start date: 2025-02-01
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2022-06-30
• Last updated: 2025-05-21

Locations

1 site across 1 country: South Korea