RecruitingPhase 2NCT06376292

A Prospective Single Arm Phase II Exploratory Study on the Combination of Whole Brain Radiotherapy, Thiotepa Intrathecal Injection and Systemic Treatment of Primary Diseases in the Treatment of Solid Tumor Leptomeningeal Metastasis

A Prospective Single Arm Phase II Exploratory Study on the Combination of Whole Brain Radiotherapy and Thiotepa Intrathecal Injection for Systemic Treatment of Primary Diseases in the Treatment of Solid Tumor Leptomeningeal Metastasis


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

58 participants

Start Date

Jan 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this prospective, single-arm exploratory clinical study is to explore the safty and efficacy of whole-brain radiotherapy combined with Thiotepa intrathecal injection combined with systemic therapy for the primary disease in the treatment of leptoeningeal metastases in solid tumors How works well was the combined therapy? How safe was combined therapy? Participants will continue systemic treatment, receive HA-WBRT combined with intrathecal injection of Thiotepa. Evaluate the efficacy and safety every 6 cycles. Researchers will evaluate whether this combination treatment is safe and whether it is more effective than previous studies.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of whole-brain radiation, a chemotherapy drug injected directly into the spinal fluid (thiotepa), and treatment for the original cancer in patients whose solid tumor cancer has spread to the lining of the brain and spinal cord (called leptomeningeal metastasis). **You may be eligible if...** - You are 18 or older with a solid tumor cancer that has spread to the brain/spinal membranes, diagnosed by established guidelines - You have already completed a specific whole-brain radiation treatment regimen - Your general health score (ECOG) is 2 or less - You have an expected survival of at least 3 months - Your organ and bone marrow function are adequate **You may NOT be eligible if...** - You have not yet received the required whole-brain radiation - Your general health is too poor to tolerate further treatment - You have severe organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIntrathecal Injection of Thiotepa+Radiation+Systemic Treatment of Primary Diseases

Participants will receive a comprehensive treatment plan consisting mainly of whole brain 30Gy/10F radiotherapy combined with intrathecal injection of Thiotepa. The injection was administered by qualified individuals (certified personnel in the radiotherapy department of our hospital) twice a week for a total of 4 weeks. Thiotepa was injected 10mg each time, mixed with cerebrospinal fluid, and then injected slowly for 5-10 minutes.


Locations(1)

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06376292