RecruitingPhase 2NCT07193654

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


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

38 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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。


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding a chemotherapy drug called thiotepa (injected into the spinal fluid) to the standard brain cancer treatment (Stupp protocol: radiation plus temozolomide chemotherapy) improves outcomes for people with newly diagnosed grade 4 brain tumors that have spread into the fluid-filled spaces of the brain or spinal cord. **You may be eligible if...** - You are between 18 and 75 years old with a newly diagnosed WHO grade 4 brain tumor (such as glioblastoma) - Imaging suggests your tumor has invaded the ventricles or the lining of the brain (meninges) - Cancer cells were found in your cerebrospinal fluid (spinal fluid) before radiotherapy - Your surgery involved opening a ventricle or fluid-filled space in the brain - Your general health score (ECOG) is 0–2 and your expected survival is at least 3 months - Your blood counts and organ function meet the required levels **You may NOT be eligible if...** - Your tumor has not spread into ventricular or meningeal spaces - No cancer cells were found in your spinal fluid - Your blood counts, liver, or kidney function are outside the required ranges Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntrathecal injection of thiotepa

Intrathecal injection of thiotepa: Administered via lumbar puncture or OMMAYA reservoir according to the study protocol.

DRUGStupp 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;

RADIATIONRadical radiotherapy

Radical radiotherapy: Delivery of 60 Gy of radiation, typically divided into 30 fractions of 2 Gy each;

PROCEDUREMaximal 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

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NCT07193654


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