Hippocampal avoidance during craniospinal irradiation for breast and lung cancer with leptomeningeal metastases
A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors
This study is testing a new way of giving radiation therapy to help people with breast or lung cancer that has spread to their brain, aiming to reduce symptoms while protecting their memory.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (San Francisco, California and 1 other locations) |
| Trial ID | NCT06518057 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial investigates the effectiveness of craniospinal irradiation (CSI) with hippocampal avoidance in patients suffering from leptomeningeal metastases due to breast cancer or non-small cell lung cancer. The study employs proton therapy or volumetric modulated arc therapy (VMAT) to target tumor cells while minimizing radiation exposure to the hippocampus, which is crucial for memory and cognitive function. Patients will receive treatment once daily for 10 days and will be monitored through various imaging techniques and follow-ups for up to a year. The goal is to relieve symptoms caused by the metastases while reducing neurological side effects associated with traditional radiation therapy.
Who should consider this trial
Good fit: Ideal candidates include adults with breast cancer or non-small cell lung cancer who have confirmed leptomeningeal metastases and are eligible for radiation therapy.
Not a fit: Patients with other types of cancer or those who do not have leptomeningeal metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and quality of life for patients with leptomeningeal metastases.
How similar studies have performed: While the approach of hippocampal avoidance in radiation therapy is gaining interest, this specific application in leptomeningeal metastases is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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 two highly effective contraceptive methods 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
Where this trial is running
San Francisco, California and 1 other locations
- University of California San Francisco — San Francisco, California, United States (Not_yet_recruiting)
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Lia M. Halasz — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Lia M. Halasz
- Email: lhalasz@uw.edu
- Phone: 206-897-2121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.