[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651245":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":37,"locations":43,"responsibleParty":56,"collaborators":27,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":27,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":87,"whyStopped":27,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Tianjin Medical University General Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group","EXPERIMENTAL","Participants receive levetiracetam extended-release granules in combination with the standard Stupp regimen.",[13,14,15],"Drug: Levetiracetam Extended-Release Granules","Drug: Temozolomide (TMZ)","Radiation: Radiotherapy",{"label":17,"type":18,"description":19,"interventionNames":20},"Control Group","ACTIVE_COMPARATOR","Participants receive the standard Stupp regimen alone.",[14,15],[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Levetiracetam Extended-Release Granules","Oral levetiracetam extended-release granules administered according to the study protocol.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Temozolomide (TMZ)","Temozolomide administered according to the standard Stupp regimen.",[17,9],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"RADIATION","Radiotherapy","Standard external beam radiotherapy administered according to the Stupp regimen.",[17,9],[38],{"name":39,"role":40,"phone":41,"phoneExt":27,"email":42},"Longtao Cui, doctor","CONTACT","19358023216","clt664141691@163.com",[44],{"facility":5,"status":27,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":27},"Tianjin","Tianjin Municipality","300052","China","CN",{"type":51,"coordinates":52},"Point",[53,54],117.17667,39.14222,{"lat":54,"lon":53},{"type":57,"investigatorFullName":58,"investigatorTitle":5,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Chunsheng Kang","100651245","phase-2-levetiracetam-extended-release-plus-stupp-protocol-for-hypoxic-idh-wildtype-glioblastoma-100651245",false,"NCT07758062","Levetiracetam Extended-Release Plus Stupp Protocol for Hypoxic IDH-Wildtype Glioblastoma","A Multicenter Prospective Cohort Study Evaluating Levetiracetam Extended-Release in Combination With Stupp Protocol for IDH-Wildtype Glioblastoma (ELITE)","ELITE","Inclusion Criteria:\n\n* Age ≥18 and \\\u003C70 years. Histopathologically confirmed primary IDH-wildtype glioblastoma (WHO CNS Grade 4, 2021 WHO Classification).\n\nTumor with hypoxic features confirmed by immunohistochemistry (HIF-1α and CA9 expression score ≥2).\n\nPlanned to receive standard Stupp protocol after maximal safe surgical resection.\n\nKarnofsky Performance Status (KPS) ≥70.\n\nAdequate bone marrow function:\n\nHemoglobin ≥90 g\u002FL Platelet count ≥100 × 10⁹\u002FL White blood cell count ≥3.0 × 10⁹\u002FL Absolute neutrophil count ≥1.5 × 10⁹\u002FL\n\nAdequate hepatic function:\n\nAST and ALT ≤2.5 × upper limit of normal (ULN) Total bilirubin \\\u003C50 μmol\u002FL.\n\nAdequate renal function:\n\nSerum creatinine ≤1.5 × ULN Creatinine clearance (CrCl) ≥36 mL\u002Fmin. No previous chemotherapy, radiotherapy, immunotherapy, or targeted therapy for glioblastoma.\n\nNo history of epilepsy or prior antiepileptic drug treatment. Ability to understand the study procedures and provide written informed consent.\n\nWilling and able to comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n* Known hypersensitivity to levetiracetam, pyrrolidone derivatives, or any study drug component.\n\nHistory 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.\n\nUncontrolled metabolic disorders or severe infections. Active hepatitis B, hepatitis C, HIV infection, active syphilis, or active tuberculosis.\n\nParticipation in another interventional clinical trial within 4 weeks before screening.\n\nHistory 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.\n\nAny other condition that, in the investigator's judgment, would make participation unsafe or interfere with study evaluation.","ALL","18 Years","69 Years",{"count":71,"type":72},140,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","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.",[78],"Glioblastoma",[78,80,81,82,83,84,85,86],"IDH-Wildtype","Hypoxia","Levetiracetam","Stupp Regimen","Temozolomide","Progression-Free Survival","HIF-1α","NOT_YET_RECRUITING","2026-08-06",{"date":90,"type":91},"2026-08-11","ACTUAL",{"date":93,"type":72},"2026-09-01",{"date":95,"type":72},"2029-09-01",{"name":5,"class":6},1]