Status:
RECRUITING
Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer
Lead Sponsor:
University of Washington
Conditions:
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 wit...
Detailed Description
OUTLINE: 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 may also underg...
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
Key Trial Info
Start Date :
March 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06518057
Start Date
March 3 2025
End Date
December 30 2027
Last Update
December 11 2025
Active Locations (2)
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1
University of California San Francisco
San Francisco, California, United States, 94143
2
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109