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NCT07758062

PHASE2

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

Sponsor: Tianjin Medical University General Hospital

View on ClinicalTrials.gov

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.

Official title: A Multicenter Prospective Cohort Study Evaluating Levetiracetam Extended-Release in Combination With Stupp Protocol for IDH-Wildtype Glioblastoma (ELITE)

Key Details

Gender

All

Age Range

18 Years - 69 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-09-01

Completion Date

2029-09-01

Last Updated

2026-08-11

Healthy Volunteers

Conditions

Glioblastoma

Interventions

DRUG

Levetiracetam Extended-Release Granules

Oral levetiracetam extended-release granules administered according to the study protocol.

DRUG

Temozolomide (TMZ)

Temozolomide administered according to the standard Stupp regimen.

RADIATION

Radiotherapy

Standard external beam radiotherapy administered according to the Stupp regimen.

Inclusion Criteria: * Age ≥18 and \<70 years. Histopathologically confirmed primary IDH-wildtype glioblastoma (WHO CNS Grade 4, 2021 WHO Classification). Tumor with hypoxic features confirmed by immunohistochemistry (HIF-1α and CA9 expression score ≥2). Planned to receive standard Stupp protocol after maximal safe surgical resection. Karnofsky Performance Status (KPS) ≥70. Adequate bone marrow function: Hemoglobin ≥90 g/L Platelet count ≥100 × 10⁹/L White blood cell count ≥3.0 × 10⁹/L Absolute neutrophil count ≥1.5 × 10⁹/L Adequate hepatic function: AST and ALT ≤2.5 × upper limit of normal (ULN) Total bilirubin \<50 μmol/L. Adequate renal function: Serum creatinine ≤1.5 × ULN Creatinine clearance (CrCl) ≥36 mL/min. No previous chemotherapy, radiotherapy, immunotherapy, or targeted therapy for glioblastoma. No history of epilepsy or prior antiepileptic drug treatment. Ability to understand the study procedures and provide written informed consent. Willing and able to comply with study procedures and follow-up. Exclusion Criteria: * Known hypersensitivity to levetiracetam, pyrrolidone derivatives, or any study drug component. History of epilepsy or previous treatment with antiepileptic drugs. Requirement for concomitant use of other antiepileptic drugs during the study. Presence of another active malignancy. Severe cardiac, hepatic, renal, hematologic, or other uncontrolled systemic diseases. Uncontrolled metabolic disorders or severe infections. Active hepatitis B, hepatitis C, HIV infection, active syphilis, or active tuberculosis. Participation in another interventional clinical trial within 4 weeks before screening. History of organ transplantation or hematopoietic stem cell transplantation. Pregnancy or breastfeeding, or plans for pregnancy during the study period. Psychiatric illness, cognitive impairment, or poor compliance that would interfere with study participation. Any other condition that, in the investigator's judgment, would make participation unsafe or interfere with study evaluation.

Locations (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China