To compare the efficacy and safety of Lenvatinib combined with the standard Stupp regimen versus the standard Stupp regimen alone in the treatment of newly diagnosed glioblastoma with MGMT promoter methylation positive.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
Chemotherapy:Lenvatinib-TMZ Group: During RT, TMZ 75 mg/m² po QD and Lenvatinib 20 mg po QD; 4 weeks after RT, 6 cycles of TMZ maintenance; Lenvatinib continues at 20 mg QD post-RT until progression or intolerable toxicity.
Chemotherapy: TMZ Group: During RT, TMZ 75 mg/m² po QD; 4 weeks after RT, 6 cycles
Starts 2-6 weeks post-op; total dose 60 Gy (2.0 Gy/fraction, 30 fractions) over 6-7 weeks.
Progression-Free Survival（PFS）
defined as the time from enrollment to the first documented local-regional recurrence, distant metastasis, or death from any cause
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Overall survival (OS)
defined as the time from enrollment to death from any cause.
Time frame: From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 36 months
Best Overall Response (BOR)
determined by modified RANO criteria for patients with incomplete tumor resection and documented postoperative residual tumor.
Time frame: 36 months
Safety evaluation
Adverse events (AE) and serious adverse events (SAE) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE V5.0).
Time frame: During the concurrent chemoradiotherapy phase; Weekly during maintenance chemotherapy cycles 1-6 (the worst result within each cycle will be recorded); At the end of treatment or disease progression. whichever came first, assessed up to 36 months.
Function quality of Life
Aassessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 ( (EORTC QLQ-C30) : Scores are converted to 0-100 scale. Higher scores indicate better functioning and quality of life for functional and global health/QoL domains, while higher symptom scores indicate greater symptom burden.
Time frame: Before the concurrent chemoradiotherapy phase; Weekly before maintenance chemotherapy cycles 1-6 (the worst result within each cycle will be recorded); At the end of treatment or disease progression. whichever came first, assessed up to 36 months.
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Brain tumor symptom burden
Assessed using the EORTC QLQ-BN20: Scores are converted to 0-100 scale. Higher symptom domain scores indicate more severe disease-related symptoms.
Time frame: Before the concurrent chemoradiotherapy phase; Weekly before maintenance chemotherapy cycles 1-6 (the worst result within each cycle will be recorded); At the end of treatment or disease progression. whichever came first, assessed up to 36 months.