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

RecruitingPhase 2Ages 18 Years - 75 YearsAllSecond Affiliated Hospital, Zhejiang University, …
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In plain words

What the trial is, and whether it could suit you

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。

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Aged 18 - 75, any gender. * Newly diagnosed WHO grade 4 brain tumor with at least one evaluable lesion, imaging suggesting ventricular or meningeal invasion. * History of intraoperative intraventricular or cisternal opening. * Malignant cells found in cerebrospinal fluid pre-radiotherapy. * ECOG score 0 - 2, expected survival≥3 months. * Stable neurological symptoms for over 7 days. * Neutrophil count≥1.5×10⁹/L, hemoglobin≥90 g/L, platelet count≥75×10⁹/L. * PT/INR and PTT≤1.5×upper limit of normal. * Total bilirubin≤1.5×upper limit of normal, AST and ALT≤1.5×upper limit of normal, albumin≥30 g/L, creatinine≤2×upper limit of normal, calculated or 24-hour urine creatinine clearance rate≥50 mL/min. * Agree to effective contraception from first to 3 months after last dose. Exclusion Criteria: * Pregnant or breastfeeding women. * Active infection within 7 days before starting study drug requiring IV antibiotics or therapeutic warfarin. * Other malignancies in past 5 years. * HIV/AIDS history; past immunodeficiency, or active autoimmune disease needing systemic treatment. * Severe medical, neurological, or psychiatric conditions preventing full adherence to study treatment or assessments. * Ventricular drainage tube rupture or inability to undergo lumbar puncture. * Uncontrolled chronic diseases like diabetes, CHF, liver cirrhosis, or CKD.
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What it tests

  • Intrathecal injection of thiotepa
  • Stupp regimen (oral temozolomide)
  • Radical radiotherapy
  • Maximal surgical resection
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Where

1 site
2nd Affiliated Hospital, School of Medicine
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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