NCT06518057RecruitingPhase 2
Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer
A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- First submitted
- 18 Jul 2024
- Start date
- 3 Mar 2025
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- University of Washington
- Diseases
- Lung cancer, Metastatic breast cancer
- NCT number
- NCT06518057
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 22
- From 3 Mar 2025 to the primary completion date, 1 Jul 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances
- Brain metastases within 5 mm of the hippocampal contours not previously treated
Other illness
- Patients with extensive systemic disease and without reasonable systemic treatment options
- Gross ventricular disease
Other
- Patients with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy
- Patients who are unable to undergo MRI brain and spine with gadolinium contrast
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Not yet recruiting |
| Fred Hutch/University of Washington Cancer Consortium Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.