Levetiracetam Extended-Release Plus Stupp Protocol for Hypoxic IDH-Wildtype Glioblastoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Levetiracetam Extended-Release Granules: Oral levetiracetam extended-release granules administered according to the study protocol.
Temozolomide (TMZ): Temozolomide administered according to the standard Stupp regimen.
Radiotherapy: Standard external beam radiotherapy administered according to the Stupp regimen.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) — Up to 24 months
Progression-free survival, defined as the time from study enrollment to disease progression or death from any cause, whichever occurs first.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality |
More Tianjin Medical University General Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07758062 on ClinicalTrials.gov ↗ ← All trials in China