Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer
Launched by UNIVERSITY OF WASHINGTON · Jul 18, 2024
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new way to deliver radiation therapy called craniospinal irradiation (CSI) for patients with breast cancer or non-small cell lung cancer that has spread to the cerebrospinal fluid and the protective layers around the brain and spinal cord, known as leptomeningeal metastases. The goal is to see if using a technique called hippocampal avoidance can reduce side effects while still effectively treating the cancer. The hippocampus is a part of the brain that is crucial for memory, and avoiding it during radiation could help prevent neurological issues.
To be eligible for this trial, participants must be at least 18 years old and have confirmed leptomeningeal metastases from either breast cancer or non-small cell lung cancer. They also need to be able to tolerate radiation therapy and meet certain health criteria, such as having a sufficient blood count. Participants can expect to receive specialized radiation treatment while being monitored for side effects. It’s important to know that this trial is currently recruiting and aims to improve treatment options for patients facing these challenging conditions.
Gender
ALL
Eligibility criteria
- Inclusion 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 an effective contraceptive method
- Exclusion 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
About University Of Washington
The University of Washington (UW) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust network of interdisciplinary teams, UW fosters collaboration among top-tier researchers, clinicians, and healthcare professionals, aiming to translate scientific discoveries into impactful treatments and interventions. The university is dedicated to ethical research practices and participant safety, ensuring rigorous adherence to regulatory standards in all clinical trials. Through its state-of-the-art facilities and extensive expertise, UW strives to address pressing health challenges and improve patient outcomes on a local and global scale.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seattle, Washington, United States
Patients applied
Trial Officials
Lia M. Halasz
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported