An interventional study of Radiation Treatments Using Brain- Avoidant Proton Craniospinal Irradiation (BRAVO- pCSI) in Leptomeningeal Metastasis, Breast Cancer and Lung Cancer (NSCLC), sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
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.
146 studies on the registry are indexed under Meningeal Carcinomatosis; 47 are open to participants now.
This study's planned enrollment of 40 is above the median of 30 across 128 interventional studies indexed under Meningeal Carcinomatosis.
Browse Meningeal Carcinomatosis studies →University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Radiation: Radiation Treatments Using Brain- Avoidant Proton Craniospinal Irradiation (BRAVO- pCSI)
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.
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.
Central Nervous System Progression Free Survival (CNS PFS)
Central Nervous System Progression Free Survival (CNS PFS) is defined as the elapsed time from start of brain-avoidant pCSI until the date of first event of CNS disease progression or death.
Time frame: Up to 1.5 years
Overall Survival (OS) after brain-avoidant pCSI
Overall Survival (OS) is defined as the elapsed time from start of brain-avoidant pCSI until date of death from any cause.
Time frame: Up to 1.5 years
Treatment Response Rate After Brain-Avoidant Proton Craniospinal Irradiation (BRAVO-pCSI)
Response rate is defined as the proportion of participants showing best responses per Response Assessment in Neuro-Oncology Leptomeningeal Metastases (RANO LM) criteria.
Time frame: Up to 1.5 years
Evaluation of the Safety And Tolerability of Brain-Avoidant Proton Craniospinal Irradiation (BRAVO-pCSI)
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to brain-avoidant pCSI, as assessed using the NCI CTCAE Version 5.0.
Time frame: Up to 1.5 years
Rate of Cognitive Failure After Brain-Avoidant Proton Craniospinal Irradiation (BRAVO-pCSI)
Cognitive failure measured via the reliable change index (RCI) after BRAVO pCSI.
Time frame: 3 months
Patient-Reported Depression
Depression will be assessed using the Center for Epidemiologic Studies Depression Scale (CES-D). Total scores range from 0 to 60, with higher scores indicating greater depressive symptoms.
Time frame: Up to 1.5 years
Patient-Reported Fatigue
Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Subscale Version 4 (Items 1-13). Total scores range from from 0 to 52, with higher scores indicating less fatigue.
Time frame: Up to 1.5 years
Mean Symptom Severity Score (MDASI-BT)
Mean score on the symptom severity subscale of the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT). Scores range from 0 to 10, with higher scores indicating greater symptom severity.
Time frame: Up to 1.5 years
Mean Disease-Specific Symptom Score (MDASI-BT)
Mean score on the brain tumor-specific symptom subscale of the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT). Scores range from 0 to 10, with higher scores indicating greater symptom burden.
Time frame: Up to 1.5 years
Mean Symptom Interference Score (MDASI-BT)
Mean score on the symptom interference subscale of the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT). Scores range from 0 to 10, with higher scores indicating greater symptom interference.
Time frame: Up to 1.5 years
Mean Symptom Severity Score (MDASI-SP)
Mean score on the symptom severity subscale of the MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP). Scores range from 0 to 10, with higher scores indicating greater symptom severity.
Time frame: Up to 1.5 years
Mean Disease-Specific Symptom Score (MDASI-SP)
Mean score on the spine tumor-specific symptom subscale of the MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP). Scores range from 0 to 10, with higher scores indicating greater symptom burden
Time frame: Up to 1.5 years
Mean Symptom Interference Score (MDASI-SP)
Mean score on the symptom interference subscale of the MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP). Scores range from 0 to 10, with higher scores indicating greater symptom interference.
Time frame: Up to 1.5 years
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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