Actively Recruiting
Stupp Treatment With Intrathecal Injection of Thiotepa for Glioblastoma With Advanced Spread
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-09-26
38
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Stupp Treatment With Intrathecal Injection of Thiotepa for Glioblastoma With Advanced Spread
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, any gender
- Newly diagnosed WHO grade 4 brain tumor with at least one evaluable lesion and imaging suggesting ventricular or meningeal invasion
- History of intraoperative intraventricular or cisternal opening
- Malignant cells detected in cerebrospinal fluid before radiotherapy
- ECOG performance status score between 0 and 2, with expected survival of at least 3 months
- Stable neurological symptoms for more than 7 days
- Neutrophil count of at least 1.5 x 10^9/L, hemoglobin of at least 90 g/L, platelet count of at least 75 x 10^9/L
- PT/INR and PTT less than or equal to 1.5 times the upper limit of normal
- Total bilirubin, AST, and ALT less than or equal to 1.5 times the upper limit of normal
- Albumin level of at least 30 g/L
- Creatinine less than or equal to 2 times the upper limit of normal or creatinine clearance of at least 50 mL/min
- Agreement to use effective contraception from the first dose until 3 months after the last dose
You will not qualify if you...
- Pregnant or breastfeeding women
- Active infection within 7 days before starting the study drug that requires intravenous antibiotics or therapeutic warfarin
- Other cancers within the past 5 years
- History of HIV/AIDS, past immunodeficiency, or active autoimmune disease requiring systemic treatment
- Severe medical, neurological, or psychiatric conditions preventing full adherence to study treatment or assessments
- Ruptured ventricular drainage tube or inability to undergo lumbar puncture
- Uncontrolled chronic diseases such as diabetes, congestive heart failure, liver cirrhosis, or chronic kidney disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
T
Ting Zhang, phD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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