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

NCT07789912 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-09-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Morgan Freret, MD · University of Miami Miller School of Medicine-Sylvester Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2030-10-01
Completion
2030-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07789912 on ClinicalTrials.gov