Levetiracetam Extended-Release Plus Stupp Protocol for Hypoxic IDH-Wildtype Glioblastoma

Sponsor
Tianjin Medical University General Hospital
Study ID
NCT07758062
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • Levetiracetam Extended-Release Granules — DRUG
    Oral levetiracetam extended-release granules administered according to the study protocol.
  • Temozolomide (TMZ) — DRUG
    Temozolomide administered according to the standard Stupp regimen.
  • Radiotherapy — RADIATION
    Standard external beam radiotherapy administered according to the Stupp regimen.

Study Details

Glioblastoma (GBM) is the most common primary malignant brain tumor in adults and is associated with poor prognosis despite standard treatment with maximal safe resection followed by radiotherapy plus temozolomide (the Stupp regimen). Tumor hypoxia is associated with treatment resistance and poor clinical outcomes. This multicenter, prospective, controlled study aims to evaluate whether levetiracetam extended-release combined with the Stupp regimen improves progression-free survival and overall survival in patients with hypoxic IDH-wildtype glioblastoma while maintaining an acceptable safety profile. Eligible patients with newly diagnosed hypoxic IDH-wildtype glioblastoma will receive either levetiracetam extended-release plus the Stupp regimen or the standard Stupp regimen. Clinical efficacy, safety, and quality-of-life outcomes will be evaluated during follow-up.

Key Dates

First listed
Aug 11, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Aug 1, 2029
Completion
Sep 1, 2029

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group
    Participants receive levetiracetam extended-release granules in combination with the standard Stupp regimen.
  • Active Comparator: Control Group
    Participants receive the standard Stupp regimen alone.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to 24 months ]

Central Contacts

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