NCT07511725RecruitingPhase 2
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）
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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: Can 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? Participants will: Receive maximal safe tumor resection followed by standard radiotherapy (60 Gy/30 fractions) plus daily temozolomide (75 mg/m²). Begin thiotepa injections (via lumbar puncture or Ommaya reservoir) within 1 week of starting radiotherapy, repeated every 7 days for 6 doses. Continue standard adjuvant temozolomide (150-200 mg/m² days 1-5/28) for 6 cycles. Understand that all procedures, toxicities and survival will be tracked for 2 years, with MRI and clinical visits every 4-8 weeks. Provide CSF and blood samples for exploratory biomarkers that may predict response or resistance.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 30 Mar 2026
- Start date
- 4 Jan 2026
- Primary completion date
- 4 Jan 2028
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Glioblastoma
- NCT number
- NCT07511725
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 38
- From 4 Jan 2026 to the primary completion date, 4 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active infection requiring intravenous antibiotics within 7 days before study entry, or therapeutic anticoagulation with warfarin.
- History of any other malignancy within the previous 5 years (except adequately treated basal-cell carcinoma of skin or cervical carcinoma in-situ).
Other illness
- Known HIV infection, AIDS, immunodeficiency syndromes, or active autoimmune disease needing systemic therapy.
- Severe medical, neurological or psychiatric conditions that would preclude compliance with protocol procedures.
- Uncontrolled chronic illnesses: diabetes, congestive heart failure (NYHA III/IV), hepatic cirrhosis, chronic kidney disease stage ≥ 3b, etc.
- Any condition judged by the investigator to increase the risks of intrathecal chemotherapy or to confound toxicity assessment.
Other
- Pregnant or lactating women.
- Disrupted ventricular drainage catheter or anatomical contraindication preventing safe lumbar puncture or Ommaya reservoir placement.
Who the study is looking for
- Age 18-75 years, either sex.
- Histologically confirmed newly-diagnosed WHO grade IV glioblastoma with at least one measurable lesion on MRI.
- Must fulfil ONE of the following high-risk imaging/surgical conditions:
- Pre-operative MRI showing tumour in direct contact with the lateral ventricular sub-ventricular zone (SVZ+); OR
- Operative record and post-operative imaging documenting an intra-operative cerebro-spinal-fluid leak (ventricular entry, VE).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and estimated life expectancy ≥ 3 months.
- Neurological symptoms stable for ≥ 7 days before enrollment.
- Adequate bone-marrow reserve: neutrophils ≥ 1.5 × 10⁹/L, haemoglobin ≥ 90 g/L, platelets ≥ 75 × 10⁹/L.
- Coagulation acceptable: PT/INR and aPTT ≤ 1.5 × upper limit of normal (ULN). Hepatic: total bilirubin ≤ 1.5 × ULN, ALT \& AST ≤ 1.5 × ULN, albumin ≥ 30 g/L. Renal: serum creatinine ≤ 2 × ULN and calculated or 24-h creatinine clearance ≥ 50 mL/min.
- Reliable contraception from first dose until 3 months after the last dose for both sexes.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.