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Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma

NCT05439278 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2025-05-21

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Severance Hospital

    lead OTHER

Principal Investigators

  • Chan Woo Wee, MD, PhD · Severance Hospital

  • In Ah Kim, MD, PhD · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2028-12-31
Completion
2030-12-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05439278 on ClinicalTrials.gov