Preventive intrathecal thiotepa with standard chemoradiation for high‑risk glioblastoma

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 is a single‑arm, prospective phase II trial giving six weekly 10 mg intrathecal doses of thiotepa during the standard Stupp chemoradiotherapy for adults with newly diagnosed WHO grade 4, IDH‑wildtype glioblastoma who are at high risk for leptomeningeal metastasis because their tumor touches the subventricular zone or there was intraoperative ventricular entry. Thiotepa is delivered by lumbar puncture or Ommaya reservoir starting within one week of radiotherapy initiation while patients receive 60 Gy/30 fractions with daily temozolomide. The main outcome is freedom from leptomeningeal metastasis at one year, with secondary endpoints of overall survival, progression‑free survival, and safety/tolerability compared with historical controls. The approach is intended as a prophylactic intervention given when circulating tumor cell burden is expected to be low.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-75 years, either sex.
* Histologically confirmed newly-diagnosed WHO grade IV glioblastoma with at least one measurable lesion on MRI.
* Must fulfil ONE of the following high-risk imaging/surgical conditions:

  1. Pre-operative MRI showing tumour in direct contact with the lateral ventricular sub-ventricular zone (SVZ+); OR
  2. Operative record and post-operative imaging documenting an intra-operative cerebro-spinal-fluid leak (ventricular entry, VE).
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and estimated life expectancy ≥ 3 months.
* Neurological symptoms stable for ≥ 7 days before enrollment.
* Adequate bone-marrow reserve: neutrophils ≥ 1.5 × 10⁹/L, haemoglobin ≥ 90 g/L, platelets ≥ 75 × 10⁹/L.
* Coagulation acceptable: PT/INR and aPTT ≤ 1.5 × upper limit of normal (ULN). Hepatic: total bilirubin ≤ 1.5 × ULN, ALT \& AST ≤ 1.5 × ULN, albumin ≥ 30 g/L. Renal: serum creatinine ≤ 2 × ULN and calculated or 24-h creatinine clearance ≥ 50 mL/min.
* Reliable contraception from first dose until 3 months after the last dose for both sexes.

Exclusion Criteria:

* Pregnant or lactating women.
* Active infection requiring intravenous antibiotics within 7 days before study entry, or therapeutic anticoagulation with warfarin.
* History of any other malignancy within the previous 5 years (except adequately treated basal-cell carcinoma of skin or cervical carcinoma in-situ).
* Known HIV infection, AIDS, immunodeficiency syndromes, or active autoimmune disease needing systemic therapy.
* Severe medical, neurological or psychiatric conditions that would preclude compliance with protocol procedures.
* Disrupted ventricular drainage catheter or anatomical contraindication preventing safe lumbar puncture or Ommaya reservoir placement.
* Uncontrolled chronic illnesses: diabetes, congestive heart failure (NYHA III/IV), hepatic cirrhosis, chronic kidney disease stage ≥ 3b, etc.
* Any condition judged by the investigator to increase the risks of intrathecal chemotherapy or to confound toxicity assessment.

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Brain connectome project in adults with brain glioma undergoing surgery

  This registry collects MRI data and clinical information from adults with glioma to see how brain networks relate to surgery and recovery.

  Recruiting Northwell Health · New York, New York · NCT07927595

• Targeted radioligand therapy for recurrent glioblastoma with Lu-177 XT771

  This early-phase study tests whether a radiolabeled medicine (Lu-177 XT771) delivered directly into the tumor cavity is safe and tolerable for adults with recurrent glioblastoma.

  Recruiting at 2 sites Early Phase 1 Beijing Tiantan Hospital · Beijing, Beijing Municipality and 1 other locations · NCT07648823

• Personalized Targeted Glioblastoma Therapies Guided by Ex Vivo Drug Screening

  This trial tests whether using a patient’s own tumor cells to screen drugs can guide a personalized treatment plan for people with newly diagnosed glioblastoma undergoing short-course radiotherapy.

  Recruiting Medical University of Vienna · Vienna, State of Vienna · NCT07627334

• LITT for ultra-early GBM recurrence within 1 week of pre-radiation planning

  This study tests whether a minimally invasive laser treatment can destroy an early GBM recurrence without delaying planned radiotherapy and chemotherapy.

  Recruiting Insel Gruppe AG, University Hospital Bern · Bern · NCT07616986

• Combined intracranial and intravenous NK cell therapy for malignant brain tumors

  This trial will test whether giving adults with recurrent malignant brain tumors their own expanded and activated natural killer (NK) cells into the tumor site and into the bloodstream is safe and feasible.

  Recruiting at 3 sites Peking University Third Hospital · Beijing, Beijing Municipality and 3 other locations · NCT07552233

• Local targeted alpha therapy using 225Ac‑DOTA‑SP for newly diagnosed WHO grade 3–4 glioma

  This trial tests a local peptide‑guided alpha‑particle treatment (225Ac‑DOTA‑SP) in adults 18–80 with newly diagnosed WHO grade 3–4 glioma after initial surgery and radiochemotherapy to see if it safely targets residual tumor and improves local control.

  Recruiting at 2 sites Medical University of Warsaw · Warsaw, Poland and 1 other locations · NCT07488754

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.