Brain-avoiding proton craniospinal irradiation for leptomeningeal metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores BRAVO pCSI, a proton-based craniospinal irradiation technique designed to spare memory-avoidance brain regions while treating leptomeningeal metastases from solid tumors. Eligible adults include those with radiographically or cytologically confirmed LM from breast cancer, NSCLC, or other solid tumors, with adequate organ function and performance status. The trial is led by the University of Miami and is being conducted at a single site in Miami, FL. The primary goal is to determine the efficacy of BRAVO pCSI in this setting, with safety and tolerability monitored as part of standard follow-up. Enrollment details and full protocol are not provided in the available information.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.
2. Pathologically confirmed breast or non-small cell lung cancer (NSCLC) primary (group 1 and). Pathologically confirmed solid tumor malignancy (group 2).
3. Participants with adequate bone marrow function.
4. Participants with a Karnofsky Performance Status (KPS) ≥ 60.
5. Male and female participants ages ≥ 18 years.
6. Female participants must be of either non-childbearing potential OR must agree to practice an effective contraceptive method.
7. Male participants must be of either non-childbearing potential OR must agree to practice an effective contraceptive method.

Exclusion Criteria:

1. 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.
2. Participants with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy.
3. Participants with extensive systemic disease and without reasonable systemic treatment options.
4. Participants unable to undergo MRI brain and spine with gadolinium contrast.
5. 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.
6. Female participants who are pregnant or lactating.
7. Participants with impaired decision-making capacity.

Where it's running

• University of Miami
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Morgan Freret, MD — University of Miami Miller School of Medicine-Sylvester Cancer Center
• Study coordinator: Morgan Freret, MD
• Email: mfreret@miami.edu
• Phone: (305) 243-5470

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.