Proton Craniospinal Irradiation for Leptomeningeal Metastasis
(BRAVO-LM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Morgan Freret, MD
Principal Investigator
University of Miami Miller School of Medicine-Sylvester Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults (18+) with breast cancer or non-small cell lung cancer that has spread to the lining of the brain and spinal cord. Participants must be well enough to care for themselves, have good bone marrow function, and agree to use birth control if needed. People with severe neurological problems or certain prior treatments can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation Treatment
Participants undergo brain-avoidant proton craniospinal irradiation (BRAVO pCSI) with a prescribed dose of 30Gy in 10 fractions
Follow-up
Participants are monitored for safety, effectiveness, and cognitive function after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BRain-AVOidant Proton Craniospinal Irradiation (BRAVO pCSI)
Trial Overview
The study tests a special type of radiation called BRAVO proton craniospinal irradiation (BRAVO-pCSI), which aims to avoid damaging important areas of the brain while treating cancer that has spread to the brain and spine coverings.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
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