[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632287":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":33,"locations":39,"responsibleParty":59,"collaborators":22,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":22,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":42,"whyStopped":22,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Stupp plus intrathecal injection of thiotepa","EXPERIMENTAL","preventive thiotepa injections within 1 week of starting radiotherapy, repeated every 7 days for 6 doses. Continue standard adjuvant temozolomide (150-200 mg\u002Fm² days 1-5\u002F28) for 6 cycles.",[13,14,15],"Procedure: Maximal surgical resection","Radiation: Concomitant Chemoradiotherapy (Stupp backbone)","Drug: Preventive Intrathecal Thiotepa",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"PROCEDURE","Maximal surgical resection","Maximal-safe resection of the contrast-enhancing tumour; if VE occurs, rapid closure and post-op MRI within 72 h to document extent of resection and any blood\u002F tumour spillage into the ventricles.",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"RADIATION","Concomitant Chemoradiotherapy (Stupp backbone)","Intensity-modulated radiotherapy (IMRT) 60 Gy in 30 fractions (2 Gy\u002Ffx, 5 fx\u002Fweek). Oral temozolomide 75 mg\u002Fm² daily, starting on the first day of RT and continuing until the last fraction (≈ 42-49 days). Adjuvant Temozolomide begins 4 weeks after completion of RT: 150 mg\u002Fm² PO days 1-5 of a 28-day cycle; escalate to 200 mg\u002Fm² cycle 2 if ANC ≥ 1.5 and platelets ≥ 100 × 10⁹\u002FL.\n\nSix cycles total.",[9],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":22},"DRUG","Preventive Intrathecal Thiotepa","10 mg thiotepa once weekly for 6 consecutive weeks, beginning within 7 days of the first RT fraction. Lumbar puncture or injection via intra-operatively placed Ommaya reservoir.",[9],[34],{"name":35,"role":36,"phone":37,"phoneExt":22,"email":38},"Ting Zhang, phD.","CONTACT","+86-571-87783521","zezht@zju.edu.cn",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"2nd Affiliated Hospital, School of Medicine","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":49,"coordinates":50},"Point",[51,52],120.16142,30.29365,{"lat":52,"lon":51},[55,58],{"name":56,"role":36,"phone":57,"phoneExt":22,"email":38},"Ting Zhang, phD","057187783521",{"name":22,"role":36,"phone":22,"phoneExt":22,"email":38},{"type":60,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100632287","phase-2-prophylactic-regimen-with-intrathecal-thiotepa-in-svz-positive-or-meningeal-risk-glioblastoma-100632287",false,"NCT07511725","Prophylactic Regimen With Intrathecal Thiotepa in SVZ-positive or Meningeal-risk Glioblastoma","A Pilot Study of Prophylactic Intrathecal Thiotepa Plus the Stupp Regimen for Glioblastoma With Subventricular Zone Contact or Intraoperative Ventricular Entry（PRISM-Trial）","PRISM","Inclusion Criteria:\n\n* Age 18-75 years, either sex.\n* Histologically confirmed newly-diagnosed WHO grade IV glioblastoma with at least one measurable lesion on MRI.\n* Must fulfil ONE of the following high-risk imaging\u002Fsurgical conditions:\n\n  1. Pre-operative MRI showing tumour in direct contact with the lateral ventricular sub-ventricular zone (SVZ+); OR\n  2. Operative record and post-operative imaging documenting an intra-operative cerebro-spinal-fluid leak (ventricular entry, VE).\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and estimated life expectancy ≥ 3 months.\n* Neurological symptoms stable for ≥ 7 days before enrollment.\n* Adequate bone-marrow reserve: neutrophils ≥ 1.5 × 10⁹\u002FL, haemoglobin ≥ 90 g\u002FL, platelets ≥ 75 × 10⁹\u002FL.\n* Coagulation acceptable: PT\u002FINR and aPTT ≤ 1.5 × upper limit of normal (ULN). Hepatic: total bilirubin ≤ 1.5 × ULN, ALT \\& AST ≤ 1.5 × ULN, albumin ≥ 30 g\u002FL. Renal: serum creatinine ≤ 2 × ULN and calculated or 24-h creatinine clearance ≥ 50 mL\u002Fmin.\n* Reliable contraception from first dose until 3 months after the last dose for both sexes.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Active infection requiring intravenous antibiotics within 7 days before study entry, or therapeutic anticoagulation with warfarin.\n* History of any other malignancy within the previous 5 years (except adequately treated basal-cell carcinoma of skin or cervical carcinoma in-situ).\n* Known HIV infection, AIDS, immunodeficiency syndromes, or active autoimmune disease needing systemic therapy.\n* Severe medical, neurological or psychiatric conditions that would preclude compliance with protocol procedures.\n* Disrupted ventricular drainage catheter or anatomical contraindication preventing safe lumbar puncture or Ommaya reservoir placement.\n* Uncontrolled chronic illnesses: diabetes, congestive heart failure (NYHA III\u002FIV), hepatic cirrhosis, chronic kidney disease stage ≥ 3b, etc.\n* Any condition judged by the investigator to increase the risks of intrathecal chemotherapy or to confound toxicity assessment.","ALL","18 Years","75 Years",{"count":73,"type":74},38,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","The goal of this clinical trial is to test whether adding preventive intrathecal chemotherapy (thiotepa) to the standard Stupp regimen can lower the risk of leptomeningeal metastasis (LM) and extend survival in patients with newly diagnosed glioblastoma (GBM) whose tumors touch the sub-ventricular zone (SVZ+) or whose surgery accidentally opened the ventricle (VE). The main questions it aims to answer are:\n\nCan six weekly intrathecal injections of thiotepa (10 mg) given during chemoradiotherapy increase the chance of remaining free of LM at one year? Does the approach also prolong overall survival and progression-free survival compared with historical controls? Is the combination safe and well-tolerated in this high-risk population?\n\nParticipants will:\n\nReceive maximal safe tumor resection followed by standard radiotherapy (60 Gy\u002F30 fractions) plus daily temozolomide (75 mg\u002Fm²).\n\nBegin thiotepa injections (via lumbar puncture or Ommaya reservoir) within 1 week of starting radiotherapy, repeated every 7 days for 6 doses.\n\nContinue standard adjuvant temozolomide (150-200 mg\u002Fm² days 1-5\u002F28) for 6 cycles.\n\nUnderstand that all procedures, toxicities and survival will be tracked for 2 years, with MRI and clinical visits every 4-8 weeks.\n\nProvide CSF and blood samples for exploratory biomarkers that may predict response or resistance.",[80],"Glioblastoma (GBM)",[82,83,84,85],"Prophylactic Intrathecal chemotherapy","thiotepa","ventricular invasion","ventricular entry","2026-03-30",{"date":88,"type":89},"2026-04-06","ACTUAL",{"date":91,"type":89},"2026-01-04",{"date":93,"type":74},"2029-01-04",{"name":5,"class":6},1]