RecruitingPhase 2NCT06518057

Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer

A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors


Sponsor

University of Washington

Enrollment

22 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II clinical trial studies how well craniospinal irradiation (CSI) with hippocampal avoidance, using proton therapy or volumetric modulated arc therapy (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 (CSF) and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal metastases). Radiation therapy is an effective treatment in relieving localized symptoms caused by leptomeningeal metastases. However, the type of radiation therapy typically used does not prevent the spread of leptomeningeal disease. 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. CSI may however result in significant neurological side effects due to radiation damage to a part of the brain called the hippocampus. Hippocampal avoidance (HA) reduces the amount of radiation to the hippocampus. Proton or VMAT CSI with HA may be an effective treatment while reducing neurological side effects for patients with leptomeningeal metastases from breast cancer and NSCLC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specialized radiation technique — craniospinal irradiation (CSI) that intentionally avoids the hippocampus (the brain's memory center) — in people whose breast cancer or non-small cell lung cancer has spread to the lining of the brain and spinal cord (leptomeningeal metastases). The goal is to deliver effective treatment while preserving memory and cognitive function. **You may be eligible if...** - You have breast cancer or non-small cell lung cancer (NSCLC) that has spread to the lining of the brain or spinal fluid (leptomeningeal metastases), confirmed by imaging or spinal fluid testing - You are a candidate for radiation therapy to treat these metastases - You are 18 or older - You are functional enough to carry out some daily activities (KPS ≥ 60 or ECOG ≥ 2) **You may NOT be eligible if...** - Your cancer type is other than breast cancer or NSCLC - Your overall health is too poor to tolerate radiation - You are unable to provide consent 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 CSF sample collection

PROCEDUREComputed Tomography

Undergo PET/CT and/or CT

OTHERElectronic Health Record Review

Ancillary studies

PROCEDURELumbar Puncture

Undergo lumbar puncture

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET/CT

RADIATIONProton Beam Craniospinal Irradiation

Undergo proton CSI

OTHERSurvey Administration

Ancillary studies

RADIATIONVolume Modulated Arc Therapy

Undergo photon VMAT CSI

PROCEDUREHippocampal-Avoidance Craniospinal Irradiation

Undergo HA


Locations(2)

University of California San Francisco

San Francisco, California, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06518057


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