Status:
RECRUITING
Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma
Lead Sponsor:
Severance Hospital
Conditions:
Glioblastoma
Eligibility:
All Genders
70+ years
Phase:
PHASE3
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT05439278
Start Date
February 1 2025
End Date
December 31 2030
Last Update
May 21 2025
Active Locations (1)
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1
Severance hospital
Seoul, South Korea