Clinical trial · Interventional
Stupp Treatment With Intrathecal Injection of Thiotepa for Glioblastoma With Advanced Spread
Stupp Regimen Combined With Intrathecal Injection of Thiotepa for the Treatment of Glioblastoma With Ventricular Invasion or Meningeal Metastasis：a Prospective, Single-Arm, Exploratory Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to learn if a combined treatment approach can treat glioblastoma (GBM) with ventricular invasion or meningeal metastasis in adults. The main questions it aims to answer are: Does the combined treatment of radical radiotherapy, the Stupp regimen (oral temozolomide), and intrathecal injection of thiotepa improve progression-free survival compared to standard treatment alone? Does the combined treatment improve overall survival compared to standard treatment alone? Participants will: * Undergo maximal surgical resection of the tumor； * Receive radical radiotherapy； * Take oral temozolomide according to the Stupp regimen； * Receive intrathecal injections of thiotepa。
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma (GBM) | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intrathecal injection of thiotepa | Drug | — | UNRESOLVED |
| Maximal surgical resection | Procedure | — | UNRESOLVED |
| Radical radiotherapy | Radiation | — | UNRESOLVED |
| Stupp regimen (oral temozolomide) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stupp plus intrathecal injection of thiotepa
- interventionNames
- Drug: Intrathecal injection of thiotepa
- Drug: Stupp regimen (oral temozolomide)
- Radiation: Radical radiotherapy
- Procedure: Maximal surgical resection
Primary outcomes (1)
- measure
- Safety assessment
- timeFrame
- From first dose of study treatment until 30 days after last dose, assessed up to 52 weeks.
- description
- Incidence and severity of treatment-related adverse events using CTCAE 5.0.
Secondary outcomes (2)
- measure
- Progression-free survival
- timeFrame
- 3 months,6 months and 1 year after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 - 75, any gender. * Newly diagnosed WHO grade 4 brain tumor with at least one evaluable lesion, imaging suggesting ventricular or meningeal invasion. * History of intraoperative intraventricular or cisternal opening. * Malignant cells found in cerebrospinal fluid pre-radiotherapy. * ECOG score 0 - 2, expected survival≥3 months. * Stable neurological symptoms for over 7 days. * Neutrophil count≥1.5×10⁹/L, hemoglobin≥90 g/L, platelet count≥75×10⁹/L. * PT/INR and PTT≤1.5×upper limit of normal. * Total bilirubin≤1.5×upper limit of normal, AST and ALT≤1.5×upper limit of normal, albumin≥30 g/L, creatinine≤2×upper limit of normal, calculated or 24-hour urine creatinine clearance rate≥50 mL/min. * Agree to effective contraception from first to 3 months after last dose. Exclusion Criteria: * Pregnant or breastfeeding women. * Active infection within 7 days before starting study drug requiring IV antibiotics or therapeutic warfarin. * Other malignancies in past 5 years. * HIV/AIDS history; past immunodeficiency, or active autoimmune disease needing systemic treatment. * Severe medical, neurological, or psychiatric conditions preventing full adherence to study treatment or assessments. * Ventricular drainage tube rupture or inability to undergo lumbar puncture. * Uncontrolled chronic diseases like diabetes, CHF, liver cirrhosis, or CKD.
References
Publications (0)
Data not yet available