NCT05439278RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 21 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 178 (estimated)
- First submitted
- 21 Jun 2022
- Start date
- 1 Feb 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Severance Hospital
- Diseases
- Glioblastoma
- NCT number
- NCT05439278
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 178
- From 1 Feb 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- history of cancer other than the followings:
- 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 known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide
Other
- patients with spinal leptomeningeal carcinomatosis
- carcinoma in situ of the cervix
- patients with psychological issues that cannot comply to the protocol
- patients who are currently participating in other clinical trials
Who the study is looking for
- 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
Age in the registry: 70 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.