NCT05439278 Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma
| NCT ID | NCT05439278 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Severance Hospital |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 178 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 178 participants in total. It began in 2025-02-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Chan Woo Wee, MD, PhD
STUDY CHAIR
Severance Hospital
Frequently Asked Questions
Who can join the NCT05439278 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05439278 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 178 participants.
Is NCT05439278 currently recruiting?
Yes, NCT05439278 is actively recruiting participants. Contact the research team at wcw0108@yuhs.ac for enrollment information.
Where is the NCT05439278 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05439278 clinical trial?
NCT05439278 is sponsored by Severance Hospital. The principal investigator is Chan Woo Wee, MD, PhD at Severance Hospital. The trial plans to enroll 178 participants.
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