Stupp treatment plus intrathecal thiotepa for glioblastoma with ventricular or meningeal spread

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study adds intrathecal thiotepa to standard care (maximal surgical resection, radical radiotherapy, and temozolomide per the Stupp regimen) for adults with newly diagnosed WHO grade 4 glioblastoma and imaging or CSF evidence of ventricular or meningeal involvement. Participants undergo surgery, receive radical radiotherapy and concomitant/adjuvant oral temozolomide, and are given intrathecal thiotepa injections via ventricular or cisternal access. Key outcomes include progression-free survival and overall survival, with safety monitoring of neurologic status and laboratory parameters. Results will be compared to standard treatment outcomes to determine whether the added intrathecal therapy improves tumor control in this high-risk subgroup.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Ting Zhang, phD.
• Email: zezht@zju.edu.cn
• Phone: +86-571-87783521

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.