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STUPP Regimen With or Without Lenvatinib for Newly Diagnosed Glioblastoma With MGMT Promoter Methylation
Sponsor: Dongguan People's Hospital
Summary
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.
Official title: STUPP Regimen With or Without Lenvatinib for Newly Diagnosed Glioblastoma With MGMT Promoter Methylation: A Multicenter, Randomized Phase II Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
138
Start Date
2026-08-10
Completion Date
2029-07-31
Last Updated
2026-08-10
Healthy Volunteers
No
Interventions
Lenvatinib
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.
TMZ (Temozolomide)
Chemotherapy: TMZ Group: During RT, TMZ 75 mg/m² po QD; 4 weeks after RT, 6 cycles
radiotherapy
Starts 2-6 weeks post-op; total dose 60 Gy (2.0 Gy/fraction, 30 fractions) over 6-7 weeks.