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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment22 people
  • Recruiting US sites2
  • SponsorUniversity of Washington
  • RegistryNCT06518057

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer: a one-minute explainerNCT065180571 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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

You cannot join if

  • 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • Biospecimen Collection (Procedure): Undergo CSF sample collection
  • Computed Tomography (Procedure): Undergo PET/CT and/or CT
  • Electronic Health Record Review (Other): Ancillary studies
  • Lumbar Puncture (Procedure): Undergo lumbar puncture
  • Magnetic Resonance Imaging (Procedure): Undergo MRI
  • Positron Emission Tomography (Procedure): Undergo PET/CT
  • Proton Beam Craniospinal Irradiation (Radiation): Undergo proton CSI
  • Survey Administration (Other): Ancillary studies
  • Volume Modulated Arc Therapy (Radiation): Undergo photon VMAT CSI
  • Hippocampal-Avoidance Craniospinal Irradiation (Procedure): Undergo HA

The study

Treatment groups

Na · Single Group · masking: None

Treatment (Proton or Photon VMAT CSI) (Experimental)

Patients undergo proton or photon VMAT CSI with HA over approximately 45 minutes once daily (QD) for 10 days (Monday-Friday) in the absence of unacceptable toxicity. Patients also undergo computed tomography (CT) or positron emission tomography (PET)/CT during screening. Additionally, patients undergo additional CT for radiation planning during screening and magnetic resonance imaging (MRI) throughout the trial. Patients may also undergo lumbar puncture (LP) or alternative methods for cerebral spinal fluid (CSF) collection at the discretion of the treating physician and principal investigator throughout the study.

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • blood samples: Part of the study plan
  • CT scans: Part of the study plan; some time points described as optional
  • MRI: Part of the study plan
  • PET scans: Part of the study plan; some time points described as optional
  • questionnaires: Part of the study plan
  • lumbar puncture: Part of the study plan; some time points described as optional

Goals

What the study measures

Main goals

  • Central nervous system (CNS)-progression free survival (PFS) (Up to 12 months)

Other goals

  • Number of adverse events associated with hippocampal avoidance craniospinal irradiation (HA-CSI)
  • Neurocognitive function assessment
  • Overall survival (OS)

Planned enrollment: 22 (estimated).

Where

Recruiting US sites

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York
  • Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 13, 2026. Public record; not medical advice.

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