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

NCT07193654 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-09-26

No results posted yet for this study

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。

Conditions

  • Glioblastoma (GBM)

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;

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2027-04-01
Completion
2028-04-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07193654 on ClinicalTrials.gov