Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma
NCT ID: NCT05439278
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
178 participants
INTERVENTIONAL
2025-02-01
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hypofractionated radiochemotherapy
Radiotherapy: 40.05 Gy in 15 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
Hypofractionated radiotherapy
40.05 Gy in 15 fractions (daily treatment, 5 per week)
Temozolomide
concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
Conventional radiochemotherapy
Radiotherapy: 60 Gy in 30 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
Conventional radiotherapy
60 Gy in 30 fractions (daily treatment, 5 per week)
Temozolomide
concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
Interventions
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Hypofractionated radiotherapy
40.05 Gy in 15 fractions (daily treatment, 5 per week)
Conventional radiotherapy
60 Gy in 30 fractions (daily treatment, 5 per week)
Temozolomide
concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
70 Years
ALL
No
Sponsors
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Severance Hospital
OTHER
Responsible Party
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Chan Woo Wee, M.D., Ph.D
M.D, PhD
Principal Investigators
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Chan Woo Wee, MD, PhD
Role: STUDY_CHAIR
Severance Hospital
In Ah Kim, MD, PhD
Role: STUDY_CHAIR
Seoul National University Bundang Hospital
Locations
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Severance hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KROG 21-11
Identifier Type: -
Identifier Source: org_study_id
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