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Anatomic Stage IV Breast Cancer AJCC v8CancerLungs and breathingProcedureRadiationPhase 2

What this study is

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.

What's being tested

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo CSF sample collection

  • Computed Tomography

    Intervention · PROCEDURE

    Undergo PET/CT and/or CT

  • Electronic Health Record Review

    Intervention · OTHER

  • Lumbar Puncture

    Intervention · PROCEDURE

    Undergo lumbar puncture

  • Magnetic Resonance Imaging

    Intervention · PROCEDURE

    Undergo MRI

  • Positron Emission Tomography

    Intervention · PROCEDURE

    Undergo PET/CT

  • Proton Beam Craniospinal Irradiation

    Intervention · RADIATION

    Undergo proton CSI

  • Survey Administration

    Intervention · OTHER

  • Volume Modulated Arc Therapy

    Intervention · RADIATION

    Undergo photon VMAT CSI

  • Hippocampal-Avoidance Craniospinal Irradiation

    Intervention · PROCEDURE

    Undergo HA

Both Electronic Health Record Review and Survey Administration

Ancillary studies

Study details

Official title
A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors
Sponsor
University of Washington
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
Enrolling
22 people
Starts
2025-03-03
Est. completion
2028-07-01
Design
Open-label, single group, Phase 2
Record
View on ClinicalTrials.gov ↗