STUPP Regimen With or Without Lenvatinib for Newly Diagnosed Glioblastoma With MGMT Promoter Methylation

Sponsor
Dongguan People's Hospital
Study ID
NCT07754734
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Glioblastoma (GBM)
  • Glioma
  • MGMT-Methylated Glioblastoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Lenvatinib — DRUG
    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) — DRUG
    Chemotherapy: TMZ Group: During RT, TMZ 75 mg/m² po QD; 4 weeks after RT, 6 cycles
  • radiotherapy — RADIATION
    Starts 2-6 weeks post-op; total dose 60 Gy (2.0 Gy/fraction, 30 fractions) over 6-7 weeks.

Study Details

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.

Key Dates

First listed
Aug 10, 2026
Start date
Aug 10, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
138 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: experimental group：Lenvatinib + TMZ + radiotherapy
    Lenvatinib + TMZ + radiotherapy：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.
  • Active Comparator: control group：TMZ + radiotherapy
    TMZ + radiotherapy：During RT, TMZ 75 mg/m² po QD; 4 weeks after RT, 6 cycles of TMZ (150-200 mg/m² po D1-D5, Q4W) maintenance.

Primary Outcome Measure

Progression-Free Survival（PFS） [ 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 ]

Central Contacts

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