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

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

Plain Language Summary

Simplified for easier understanding

This study is comparing two radiation schedules for elderly patients with glioblastoma (an aggressive brain cancer): a conventional schedule (daily treatments over several weeks) versus a shorter, more intense schedule (hypofractionated radiotherapy), both combined with the chemotherapy drug temozolomide. The aim is to find the approach that is most effective and easiest to tolerate in older patients. **You may be eligible if:** - You are 70 years or older - You have been newly diagnosed with glioblastoma (confirmed by pathology) - You have had surgery or biopsy within 4 weeks before joining the study - You are in reasonably good physical condition (Karnofsky score of 60 or above) - You have not previously received radiation to the brain or chemotherapy **You may NOT be eligible if:** - Your cancer has spread to the spine or spinal fluid - You have had prior brain radiation or chemotherapy - Your organ function is too poor to safely take temozolomide - You have another active cancer (with some minor exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHypofractionated radiotherapy

40.05 Gy in 15 fractions (daily treatment, 5 per week)

RADIATIONConventional radiotherapy

60 Gy in 30 fractions (daily treatment, 5 per week)

DRUGTemozolomide

concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)


Locations(1)

Severance hospital

Seoul, South Korea

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NCT05439278


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