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RECRUITING
NCT05439278
PHASE3

Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma

Sponsor: Severance Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

178

Start Date

2025-02-01

Completion Date

2030-12-31

Last Updated

2025-05-21

Healthy Volunteers

No

Conditions

Interventions

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)

Locations (1)

Severance hospital

Seoul, South Korea