RecruitingPhase 2NCT06910761

Photon Craniospinal Irradiation for the Treatment of Leptomeningeal Disease Secondary to Breast Cancer or Non-small Cell Lung Cancer

Phase II Trial of Photon Craniospinal Irradiation for Leptomeningeal Disease Secondary to Solid Tumor Malignancy


Sponsor

City of Hope Medical Center

Enrollment

35 participants

Start Date

May 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well craniospinal irradiation (CSI) using photon volumetric modulated arc radiotherapy (VMAT) works in treating patients with breast cancer or non-small cell lung cancer (NSCLC) that has spread from the original (primary) tumor to the cerebrospinal fluid and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal disease). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. CSI (radiation therapy directed at the brain and spinal cord to kill tumor cells) may be able to target all of the areas of possible leptomeningeal tumor spread. Photon-VMAT-CSI may be an effective treatment option for patients with leptomeningeal disease secondary to breast cancer or NSCLC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of radiation therapy called photon craniospinal irradiation — radiation delivered to the brain and spine — for people with breast cancer or non-small cell lung cancer that has spread to the lining of the brain and spinal cord (called leptomeningeal disease). **You may be eligible if...** - You are 18 or older - You have been diagnosed with breast cancer or non-small cell lung cancer - Cancer has spread to the lining around your brain or spinal cord (confirmed by imaging or spinal fluid testing) - You are physically well enough to handle treatment (a doctor will assess this) - Your blood counts and kidney function meet certain minimum levels - You can read English or Spanish, or complete questionnaires with an interpreter **You may NOT be eligible if...** - You received chemotherapy, immunotherapy, or targeted therapy within the last 7 days - You have had prior radiation that would prevent safe delivery of spinal radiation - You have severe neurological symptoms such as severe confusion - Your cancer outside the brain/spine is extensive and uncontrolled - You are pregnant or breastfeeding - You are unable to have an MRI with contrast dye 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.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood and CSF sample collection

RADIATIONCraniospinal Irradiation

Undergo photon-VMAT-CSI

OTHERElectronic Health Record Review

Ancillary studies

PROCEDURELumbar Puncture

Undergo LP

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREOmmaya Reservoir Tap

Undergo Ommaya reservoir tap

OTHERQuestionnaire Administration

Ancillary studies

RADIATIONVolume Modulated Arc Therapy

Undergo photon-VMAT-CSI


Locations(2)

City of Hope Medical Center

Duarte, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

View Full Details on ClinicalTrials.gov

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NCT06910761


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