BRain-AVOidant Proton Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumor Malignancies

Part of paid clinical trials in Miami, Florida.

Sponsor: University of Miami
Study ID: NCT07789912
Phase: PHASE2
Status: Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Breast Cancer
Leptomeningeal Metastasis
Lung Cancer (NSCLC)

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed: Aug 27, 2026
Start date: Oct 1, 2026
Status verified: Aug 2026
Primary completion: Oct 1, 2030
Completion: Oct 1, 2030

Study Design

Enrollment: 40 participants (estimated)
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.