NCT07789912Recruiting
BRain-AVOidant Proton Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumor Malignancies
A Phase II Study Assessing the Efficacy of BRain-AVOidant Proton Craniospinal Irradiation (CSI) for Leptomeningeal Metastases (LM) From Solid Tumor Malignancies (BRAVO-LM)
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to determine the efficacy of BRain-AVOidant proton craniospinal irradiation (BRAVO pCSI) in adult participants with leptomeningeal metastases from solid tumors.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 24 Aug 2026
- Start date
- 13 Oct 2026
- Primary completion date
- 13 Oct 2030
- Lead sponsor
- University of Miami
- Diseases
- Lung cancer
- NCT number
- NCT07789912
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 13 Oct 2026 to the primary completion date, 13 Oct 2030
- 1 site 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, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have had radiation therapy to the spinal cord with equivalent dose in 2Gy fractions (EQD2) more than 40Gy or cauda equina with EQD2 more than 50Gy using α/β of 3.
Other illness
- Participants with extensive systemic disease and without reasonable systemic treatment options.
Other
- Participants with metastases within the memory-avoidance structures (hippocampus, corpus callosum, fornix, amygdala) that preclude developing a treatment plan that respects dosimetric constraints for these structures.
- Participants with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy.
- Participants unable to undergo MRI brain and spine with gadolinium contrast.
- Female participants who are pregnant or lactating.
- Participants with impaired decision-making capacity.
Who the study is looking for
- Participants with leptomeningeal metastases established radiographically and/or through Cerebrospinal Fluid (CSF) cytology or circulating tumor cells (CTCs). Participants may have newly diagnosed or recurrent LM.
- Pathologically confirmed breast or non-small cell lung cancer (NSCLC) primary (group 1 and). Pathologically confirmed solid tumor malignancy (group 2).
- Participants with adequate bone marrow function.
- Participants with a Karnofsky Performance Status (KPS) ≥ 60.
- Male and female participants ages ≥ 18 years.
- Female participants must be of either non-childbearing potential OR must agree to practice an effective contraceptive method.
- Male participants must be of either non-childbearing potential OR must agree to practice an effective contraceptive method.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.