BRain-AVOidant Proton Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumor Malignancies
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants with leptomeningeal metastases established radiographically and/or through Cerebrospinal Fluid (CSF) cytology or circulating tumor cells (CTCs). Participants may have newly diagnosed or recurrent LM.
Pathologically confirmed breast or non-small cell lung cancer (NSCLC) primary (group 1 and). Pathologically confirmed solid tumor malignancy (group 2).
Participants with adequate bone marrow function.
Participants with a Karnofsky Performance Status (KPS) ≥ 60.
Disqualifiers
Participants with metastases within the memory-avoidance structures (hippocampus, corpus callosum, fornix, amygdala) that preclude developing a treatment plan that respects dosimetric constraints for these structures.
Participants with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy.
Participants with extensive systemic disease and without reasonable systemic treatment options.
Participants unable to undergo MRI brain and spine with gadolinium contrast.
Trial design
Design model
Parallel
Treatments tested in this trial
Radiation Treatments Using Brain- Avoidant Proton Craniospinal Irradiation (BRAVO- pCSI)
RadiationParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Radiation TreatmentExperimental treatment 1 intervention
Group B: Non-Interventional ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: