Actively Recruiting
Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer
Led by University of Washington · Updated on 2025-12-11
22
Participants Needed
2
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with breast cancer or non-small cell lung cancer with leptomeningeal metastases confirmed by imaging or cerebrospinal fluid tests
- Candidates for radiation therapy to treat leptomeningeal metastases
- 18 years of age or older
- Karnofsky performance status 60 or higher or Eastern Cooperative Oncology Group score 2 or less
- Able to provide informed consent
- Hemoglobin greater than 8 g/dL
- Absolute neutrophil count greater than 1,000/mm
- Platelet count greater than 100,000/mm
- Female participants must be non-reproductive or have a negative pregnancy test within 3 weeks before starting radiation
- Participants able to use two highly effective contraceptive methods if of reproductive potential
You will not qualify if you...
- Patients with multiple serious neurological deficits including encephalopathy
- Patients with extensive systemic disease without reasonable treatment options
- Patients unable to have MRI scans of brain and spine with gadolinium contrast
- Previous radiation therapy to the treatment area preventing safe treatment planning
- Presence of gross ventricular disease
- Untreated brain metastases within 5 mm of the hippocampus
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of California San Francisco
San Francisco, California, United States, 94143
Not Yet Recruiting
2
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
L
Lia M. Halasz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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