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Stupp Treatment With Intrathecal Injection of Thiotepa for Glioblastoma With Advanced Spread
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
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。
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2025-04-01
Completion Date
2028-04-01
Last Updated
2025-09-26
Healthy Volunteers
No
Conditions
Interventions
Intrathecal injection of thiotepa
Intrathecal injection of thiotepa: Administered via lumbar puncture or OMMAYA reservoir according to the study protocol.
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;
Radical radiotherapy
Radical radiotherapy: Delivery of 60 Gy of radiation, typically divided into 30 fractions of 2 Gy each;
Maximal surgical resection
Maximal surgical resection: Removal of as much tumor as possible while preserving neurological function;
Locations (1)
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, China