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

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.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Metastatic Breast Carcinoma
• Metastatic Lung Non-Small Cell Carcinoma
• Metastatic Malignant Neoplasm in the Leptomeninges
• Stage IV Lung Cancer AJCC v8

Interventions

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

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

Sponsors & Collaborators

• University of Washington

  lead OTHER

Principal Investigators

• Lia M. Halasz · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-03

Primary Completion

2026-12-30

Completion

2027-12-30

FDA Device

Yes

Countries

• United States

Study Locations