Comparing two types of radiotherapy with temozolomide for elderly glioblastoma patients
Official title: Randomized Phase III Study of Conventional Versus Hypofractionated Radiotherapy Combined With Temozolomide in Elderly Glioblastoma Patients
Run by Severance Hospital · NCT05439278 · Data updated 2026-11-12
This study is testing whether two different types of radiotherapy, along with a medication called temozolomide, can help older patients with newly diagnosed glioblastoma live longer and feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 70 Years and up |
| Sex | All |
| Enrollment | 178 (estimated) |
| Sponsor | Severance Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | February 1, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2030 |
| Registry record updated | May 21, 2025 |
| Trial ID | NCT05439278 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients aged 70 years or older with newly diagnosed glioblastoma who can start treatment within three weeks of randomization.
✕Probably not a fit
Patients with spinal leptomeningeal carcinomatosis or a history of other significant cancers may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of conventional radiotherapy (60 Gy over 6 weeks) versus hypofractionated radiotherapy (40 Gy over 3 weeks) in patients aged 70 and older who have newly diagnosed glioblastoma and are eligible for concurrent treatment with temozolomide. The primary focus is on overall survival, but the study will also assess progression-free survival, treatment-related toxicity, quality of life, and prognostic biomarkers. Participants must meet specific eligibility criteria, including a Karnofsky performance score of 60 or higher and no prior brain radiotherapy or systemic chemotherapy.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective radiotherapy regimen for elderly glioblastoma patients, potentially improving survival and quality of life.
How similar studies have gone: Other studies have explored radiotherapy approaches for glioblastoma, but this specific comparison of conventional versus hypofractionated radiotherapy in elderly patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
-
Severance hospital
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Chan Woo Wee, MD, PhD
- Email: wcw0108@yuhs.ac
- Phone: +82-2-2228-8121
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.