Study Comparing Proton Radiation Therapy to Standard Radiation for Cancer Spread to Brain and Spinal Fluid

Program Overview

This study is exploring two types of radiation therapy for treating cancer that has spread to the fluid-filled space around the brain and spinal cord, known as leptomeningeal metastasis. The trial compares proton craniospinal irradiation (pCSI), which uses protons for more precise targeting, to involved-field radiation therapy (IFRT), which uses x-rays to treat specific areas. The goal is to see if pCSI can better delay the worsening of symptoms and improve outcomes for patients with breast or non-small cell lung cancer.

Description

The main goal of this study is to compare the overall survival of patients receiving proton craniospinal irradiation (pCSI) versus those receiving involved-field radiotherapy (IFRT) for breast or non-small cell lung cancer that has spread to the brain and spinal fluid.

Secondary goals include comparing how long patients live without the cancer worsening in the central nervous system, the time it takes for the cancer to progress, and the rate of radiation-induced damage to the nervous system. The study also looks at side effects and how patients report their symptoms and quality of life.

Participants are randomly assigned to one of two groups:

• Group 1: Receives involved-field radiation therapy targeting specific areas causing symptoms, 5 days a week for 10 days. Participants will have CT or PET/CT scans, MRIs, and possibly lumbar punctures during the study. Optional blood and spinal fluid samples may be collected.

• Group 2: Receives proton craniospinal irradiation targeting the entire space around the brain and spinal cord, 5 days a week for 10 days. Participants will have similar tests and optional sample collections as Group 1.

After treatment, patients are monitored every 3 months for a year, then every 6 months for up to 3 years.

Eligibility Criteria

Locations