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NOT YET RECRUITING
NCT07789912
PHASE2

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

Sponsor: University of Miami

View on ClinicalTrials.gov

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.

Official title: A Phase II Study Assessing the Efficacy of BRain-AVOidant Proton Craniospinal Irradiation (CSI) for Leptomeningeal Metastases (LM) From Solid Tumor Malignancies (BRAVO-LM)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-10-01

Completion Date

2030-10-01

Last Updated

2026-08-27

Healthy Volunteers

No

Interventions

RADIATION

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.

Locations (1)

University of Miami

Miami, Florida, United States