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RECRUITING
NCT06518057
PHASE2

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

Sponsor: University of Washington

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2025-03-03

Completion Date

2027-12-30

Last Updated

2025-12-11

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo CSF sample collection

PROCEDURE

Computed Tomography

Undergo PET/CT and/or CT

OTHER

Electronic Health Record Review

Ancillary studies

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

RADIATION

Proton Beam Craniospinal Irradiation

Undergo proton CSI

OTHER

Survey Administration

Ancillary studies

RADIATION

Volume Modulated Arc Therapy

Undergo photon VMAT CSI

PROCEDURE

Hippocampal-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