Feasibility of Using Concurrent Carboplatin and Reduced Dose Craniospinal Radiation (24Gy) for Metastatic Medulloblastoma, High-Risk Supratentorial PNET and Metastatic PNET
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Event-free Survival
研究概览
简要总结
The purpose of this study is to study the efficacy of the combination of reduced dose craniospinal radiation (reduced from standard of care dosing at 36 Gy to 24 Gy) with concurrent carboplatin and vincristine administration for metastatic classical histology medulloblastomas and high-risk supratentorial PNETs and metastatic PNETs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 3 years and less than 25 years
- •Patients with classic histology or desmoplastic histology metastatic medulloblastoma by histological diagnosis and by head and spine MRI.
- •Patients with high-risk supratentorial, non-metastatic, PNET
- •Patients with metastatic PNET
- •Newly diagnosed patients who have not received prior therapy, with the exception of one short course of emergent chemotherapy in newly presenting patients with neurological compromise per provider decision
- •Only patients who are expected to survive at least 6 weeks will be eligible for this study.
排除标准
- •Patients who are pregnant may not be treated on this study
- •Patients with anaplastic histology
研究组 & 干预措施
Reduced radiation with concurrent chemotherapy
Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration
干预措施: Carboplatin (Drug)
Reduced radiation with concurrent chemotherapy
Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration
干预措施: Vincristine (Drug)
Reduced radiation with concurrent chemotherapy
Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration
干预措施: 24 Gy (Radiation)
结局指标
主要结局
Event-free Survival
时间窗: Up to 60 months.
MRIs of the head and spine. Number of participants with event free survival at 60 months is reported.
Overall Survival
时间窗: up to 5 years
Overall Survival will be measured at the end of study. number of surviving participants is reported.
Intellectual Competence Measured by IQ Score: Month 24
时间窗: Month 24
Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.
Intellectual Competence Measured by IQ Score: Month 60
时间窗: Month 60
Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.
Intellectual Competence Measured by IQ Score: Week 8
时间窗: Week 8
Neuropsychological testing will be performed after radiation in completed. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.
次要结局
未报告次要终点