Recruiting

BRAVO pCSI

Sponsor:

University of Miami

Code:

NCT07789912

Conditions

Leptomeningeal Metastasis

Breast Cancer

Lung Cancer (NSCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation Treatments Using Brain- Avoidant Proton Craniospinal Irradiation (BRAVO- pCSI)

Study Details

Brief summary:

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.

Conditions

Leptomeningeal Metastasis

Breast Cancer

Lung Cancer (NSCLC)

Study ID

NCT07789912

Start date

Oct 13, 2026

Status verified date

Oct, 2026

Completion date

Oct 13, 2030

Anticipated

Primary completion date

Oct 13, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Radiation Treatment

Participants in this group will undergo radiation treatments using brain-avoidant proton craniospinal irradiation (CSI). The prescribed radiation dose for all participants will be 30Gy (Cobalt Gray Equivalent \[CGE\]) in 10 fractions.

no intervention: Non-Interventional Arm

Participants who decline BRAVO-pCSI will have the option to enroll in a non-interventional exploratory arm. Participants in this group will undergo the same baseline and follow-up assessments as participants receiving BRAVO-pCSI, including radiographic evaluations, cerebrospinal fluid (CSF) and serum assessments, neurocognitive testing, and quality-of-life assessments. No study intervention will be administered.

Interventions

Radiation Treatments Using Brain- Avoidant Proton Craniospinal Irradiation (BRAVO- pCSI)

Participants with Leptomeningeal Metastases (LM) from breast or non-small cell lung cancer will be included in Group 1 (20 evaluable participants). Participants with LM from solid tumors of other histologies will be included in Group 2 (10 evaluable participants). All participants in Groups 1 and 2 will receive Brain-Avoidant Proton Craniospinal Irradiation (BRAVO-pCSI) at a prescribed dose of 30 Gy (Cobalt Gray Equivalent \[CGE\]) delivered in 10 fractions.

Protocol treatment must begin within 21 days of study enrollment and will be delivered over approximately 2 weeks.

Primary outcome measure

  • Central Nervous System Progression Free Survival (CNS PFS) [ Time Frame: Up to 1.5 years ]

Central Contacts and Locations

Central contacts

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Principal Investigator:

Morgan Freret, MD

More Information

Sponsor

University of Miami

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Keywords

  • breast cancer
  • lung cancer
  • leptomeningeal metastasis
  • craniospinal irradiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of Miami on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.