NCT07193654

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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。

Detailed description

Glioblastoma (GBM) is the most common and aggressive primary malignant brain tumor in adults, with a dismal prognosis despite standard treatment. The standard treatment for GBM, which includes surgery, radiotherapy, and chemotherapy with temozolomide (known as the Stupp regimen), has remained largely unchanged for over two decades. Patients with GBM who have tumor invasion of the brain ventricles or meningeal metastasis face an even worse prognosis, with significantly shorter progression-free survival and overall survival compared to patients without these complications. The blood-brain barrier poses a significant challenge to effective chemotherapy delivery, limiting the efficacy of systemic treatments for central nervous system tumors. Intrathecal chemotherapy administration represents a promising strategy to overcome this barrier by directly delivering chemotherapeutic agents into the cerebrospinal fluid, potentially improving tumor control and survival outcomes in patients at high risk for intraventricular dissemination.

Conditions

• Glioblastoma (GBM)

Interventions

Type	Name	Description
DRUG	Intrathecal injection of thiotepa	Intrathecal injection of thiotepa: Administered via lumbar puncture or OMMAYA reservoir according to the study protocol.
DRUG	Stupp regimen (oral temozolomide)	Stupp regimen (oral temozolomide)::75 mg/m² daily during radiotherapy; 150-200 mg/m² daily for 5 days every 28 days for 6 cycles after radiotherapy;
RADIATION	Radical radiotherapy	Radical radiotherapy: Delivery of 60 Gy of radiation, typically divided into 30 fractions of 2 Gy each;
PROCEDURE	Maximal surgical resection	Maximal surgical resection: Removal of as much tumor as possible while preserving neurological function;

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-04-01
• Completion: 2028-04-01
• First posted: 2025-09-26
• Last updated: 2025-09-26

Locations

1 site across 1 country: China