RecruitingPhase 2NCT06518057
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBiospecimen Collection and Computed Tomography

Plus 8 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 14, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?University of Washington

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
University of Washington
Interventions being studied
Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Electronic Health Record Review; Procedure: Lumbar Puncture; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Radiation: Proton Beam Craniospinal Irradiation; Other: Survey Administration; Radiation: Volume Modulated Arc Therapy; Procedure: Hippocampal-Avoidance Craniospinal Irradiation
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Patients with breast cancer or NSCLC malignancies with leptomeningeal metastases established radiographically and/or through CSF cytology
  • Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastases
  • Patients ≥ 18 years old
  • Karnofsky performance status (KPS) ≥ 60 or Eastern Cooperative Oncology Group (ECOG) ≥ 2
  • The patient is able to provide informed consent
  • Hemoglobin \> 8 g/dL
  • Absolute neutrophil count \> 1,000/mm
  • Platelet count \> 100,000/mm
  • Participants born female at birth must either be of non-reproductive potential (i.e. post-menopausal by history \[≥ 60 years old, or with no menses for \> 1 year without an alternative medical cause\], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum /urine pregnancy test within 3 weeks prior to starting radiation therapy (RT)
  • Patients with reproductive potential must agree to practice two highly effective contraceptive methods
Reasons someone may not be able to joinExclusion criteria
  • Patients with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy
  • Patients with extensive systemic disease and without reasonable systemic treatment options
  • Patients who are unable to undergo MRI brain and spine with gadolinium contrast
  • Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances
  • Gross ventricular disease
  • Brain metastases within 5 mm of the hippocampal contours not previously treated
  • Pregnant or lactating women

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California San FranciscoSan Francisco, California
  • Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, New York
  • Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 14, 2026. Always confirm current availability with the study team.

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