Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Participants With Toxicities Associated With GRID Radiotherapy
研究概览
简要总结
The primary objective of this study is to evaluate the toxicity profile of GRID therapy using dose levels of 10Gy, 15 Gy and 20Gy in pediatric osteosarcoma of the extremity.
详细描述
Subjects will receive GRID radiotherapy. GRID radiation therapy is considered a standard radiation therapy method however is not typically used in pediatric osteosarcoma patients. This protocol will evaluate whether or not the use of this therapy will provide benefit to this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of cytological or histological documentation of non-metastatic extremity osteosarcoma.
- •5-21 years of age.
- •Subject is eligible for routine chemotherapy and routine surgery for the treatment of non-metastatic extremity osteosarcoma
- •Informed consent is obtained
排除标准
- •Females with a positive urine pregnancy test.
- •Unable to comply with study procedures
研究组 & 干预措施
GRID Radiotherapy
Patients will be treated with GRID Radiotherapy
干预措施: GRID radiotherapy (Radiation)
结局指标
主要结局
Number of Participants With Toxicities Associated With GRID Radiotherapy
时间窗: An average of 12 months
The study endpoint is dose-limiting toxicity (DLT), which is defined as a treatment-related AE of Grade 3 or higher.
次要结局
未报告次要终点