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Craniospinal Irradiation for Leptomeningeal Metastases

This study is looking at a type of radiation therapy called craniospinal irradiation (CSI) with hippocampal avoidance. This treatment uses either proton therapy or VMAT (volumetric modulated arc therapy) to treat breast cancer or non-small cell lung cancer (NSCLC) that has spread to the brain and spinal cord lining (leptomeningeal metastases). The study wants to see how long patients live without their cancer growing in the central nervous system (CNS-progression free survival) for up to 12 months. You might be able to join if you have breast cancer or NSCLC with leptomeningeal metastases, are at least 18 years old, and are healthy enough for radiation therapy. The study plans to enroll 22 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 22 participants.
What's involved
You would receive daily radiation therapy for 10 days. You may also have CT scans, MRI scans, and lumbar punctures (spinal taps) for fluid collection.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you will have follow-up visits at 3, 6, 9, and 12 months, and then at the time of CNS disease progression, up to 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06518057

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Washington
~22 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyElectronic Health Record ReviewLumbar PunctureMagnetic Resonance ImagingPositron Emission Tomography

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Central nervous system (CNS)-progression free survival (PFS)
Measured over Up to 12 months

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

Explore related trials

Breast CarcinomaLung Non-Small Cell CarcinomaMetastatic Malignant Neoplasm in the Leptomeninges

Where it's being run

3 sites across 3 states
California1
New York1
Washington1

Study leadership

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

Who to contact

Lia M. Halasz
[email protected]
206-897-2121
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

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

    PFS is defined as time from craniospinal irradiation (CSI) to CNS disease progression or death. CNS-PFS will be summarized using Kaplan-Meier methodology. Median, 95% confidence interval (CI) and Kaplan-Meier plot will be provided. One-sample log-rank test will be used to test if the median CNS PFS of hippocampal avoidance in CSI for leptomeningeal metastases from breast cancer or non-small cell lung cancer (NSCLC) is significantly larger than the expected median CNS PFS with involved-field radiation therapy (IFRT), i.e., 2.5 months. P-value will be provided.