Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06518057

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here