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RECRUITING
NCT07193654
PHASE2

Stupp Treatment With Intrathecal Injection of Thiotepa for Glioblastoma With Advanced Spread

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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

Interventions

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;

Locations (1)

2nd Affiliated Hospital, School of Medicine

Hangzhou, Zhejiang, China