Actively Recruiting
Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma
Led by Severance Hospital · Updated on 2025-05-21
178
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed glioblastoma according to the 2021 WHO classification
- Diagnosis to randomization interval of 4 weeks or less
- Age 70 years or older
- Gadolinium-enhanced MRI within 72 hours after surgery
- Known MGMT promoter methylation status
- Karnofsky performance score 60 or higher
- Stable or decreasing steroid dose if needed
- No history of brain radiotherapy
- No prior systemic chemotherapy
- Adequate blood, kidney, and liver function for temozolomide
- Able to start radiotherapy within 3 weeks of randomization
You will not qualify if you...
- Spinal leptomeningeal carcinomatosis
- History of cancer except for carcinoma in situ of the cervix, fully removed non-melanoma skin cancer, or cancers with no residual disease for 5 years or more
- Serious active infection or other serious medical conditions
- Psychological issues preventing protocol compliance
- Known allergy to temozolomide or similar compounds
- Currently enrolled in other clinical trials
AI-Screening
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Trial Site Locations
Total: 1 location
1
Severance hospital
Seoul, South Korea
Actively Recruiting
Research Team
C
Chan Woo Wee, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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