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

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。

Interventions

• Intrathecal injection of thiotepa · DRUG

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

• Stupp regimen (oral temozolomide) · DRUG

  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;

• Radical radiotherapy · RADIATION

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

• Maximal surgical resection · PROCEDURE

  Maximal surgical resection: Removal of as much tumor as possible while preserving neurological function;

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (1)

• 2nd Affiliated Hospital, School of Medicine, Hangzhou, Zhejiang, China · RECRUITING