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

NCT ID: NCT07193654

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2028-04-01

Brief 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。

Detailed Description

Glioblastoma (GBM) is the most common and aggressive primary malignant brain tumor in adults, with a dismal prognosis despite standard treatment. The standard treatment for GBM, which includes surgery, radiotherapy, and chemotherapy with temozolomide (known as the Stupp regimen), has remained largely unchanged for over two decades. Patients with GBM who have tumor invasion of the brain ventricles or meningeal metastasis face an even worse prognosis, with significantly shorter progression-free survival and overall survival compared to patients without these complications. The blood-brain barrier poses a significant challenge to effective chemotherapy delivery, limiting the efficacy of systemic treatments for central nervous system tumors. Intrathecal chemotherapy administration represents a promising strategy to overcome this barrier by directly delivering chemotherapeutic agents into the cerebrospinal fluid, potentially improving tumor control and survival outcomes in patients at high risk for intraventricular dissemination.

Conditions

Glioblastoma (GBM)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stupp plus intrathecal injection of thiotepa

Group Type: EXPERIMENTAL

Intrathecal injection of thiotepa

Intervention Type: DRUG

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

Stupp regimen (oral temozolomide)

Intervention Type: 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

Intervention Type: RADIATION

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

Maximal surgical resection

Intervention Type: PROCEDURE

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

Interventions

Intrathecal injection of thiotepa

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

Intervention Type: DRUG

Stupp regimen (oral temozolomide)

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;

Intervention Type: DRUG

Radical radiotherapy

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

Intervention Type: RADIATION

Maximal surgical resection

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

2nd Affiliated Hospital, School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ting Zhang, phD.

Role: CONTACT

zezht@zju.edu.cn

+86-571-87783521

Facility Contacts

Ting Zhang phD

Role: primary

zezht@zju.edu.cn

+86571-87783521

phD

Role: backup

Other Identifiers

Y2025-0127

Identifier Type: -

Identifier Source: org_study_id