A Phase II Study Assessing the Efficacy of BRain-AVOidant Proton Craniospinal Irradiation (CSI) for Leptomeningeal Metastases (LM) From Solid Tumor Malignancies (BRAVO-LM)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Central Nervous System Progression Free Survival (CNS PFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) ≥
- •Male and female participants ages ≥ 18 years.
- •Female participants must be of either non-childbearing potential OR must agree to practice an effective contraceptive method.
- •Male participants must be of either non-childbearing potential OR must agree to practice an effective contraceptive method.
排除标准
- •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.
- •Participants who have had radiation therapy to the spinal cord with equivalent dose in 2Gy fractions (EQD2) more than 40Gy or cauda equina with EQD2 more than 50Gy using α/β of
- •Female participants who are pregnant or lactating.
- •Participants with impaired decision-making capacity.
研究组 & 干预措施
Radiation Treatment
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.
干预措施: Radiation Treatments Using Brain- Avoidant Proton Craniospinal Irradiation (BRAVO- pCSI) (Radiation)
Non-Interventional Arm
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.
结局指标
主要结局
Central Nervous System Progression Free Survival (CNS PFS)
时间窗: Up to 1.5 years
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.
次要结局
- Overall Survival (OS) after brain-avoidant pCSI(Up to 1.5 years)
- Treatment Response Rate After Brain-Avoidant Proton Craniospinal Irradiation (BRAVO-pCSI)(Up to 1.5 years)
- Evaluation of the Safety And Tolerability of Brain-Avoidant Proton Craniospinal Irradiation (BRAVO-pCSI)(Up to 1.5 years)
- Rate of Cognitive Failure After Brain-Avoidant Proton Craniospinal Irradiation (BRAVO-pCSI)(3 months)
- Patient-Reported Quality of Life(Up to 1.5 years)
- Patient-Reported Depression(Up to 1.5 years)
- Patient-Reported Fatigue(Up to 1.5 years)
- Mean Symptom Severity Score (MDASI-BT)(Up to 1.5 years)
- Mean Disease-Specific Symptom Score (MDASI-BT)(Up to 1.5 years)
- Mean Symptom Interference Score (MDASI-BT)(Up to 1.5 years)
- Mean Symptom Severity Score (MDASI-SP)(Up to 1.5 years)
- Mean Disease-Specific Symptom Score (MDASI-SP)(Up to 1.5 years)
- Mean Symptom Interference Score (MDASI-SP)(Up to 1.5 years)
研究者
Morgan Freret
Assistant Professor
University of Miami