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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
University of Miami
Miami, Florida, United States
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
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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