NCT03139318终止不适用
Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 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
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
研究者
研究点 (2)
Loading locations...
相似试验
招募中
1 期
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive TumorsRhabdomyosarcomaLymphomaGISTNCT06441331ITM Solucin GmbH20
终止
1 期
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung CancersLung CancerOvarian CancerNCT06376253Novartis Pharmaceuticals4
已完成
1 期
Phase I Trial of BAY1251152 for Advanced Blood CancersHematologic NeoplasmsNCT02745743Bayer21
撤回
1 期
LDFWART With Docetaxel in Patients With Platinum-Resistant Recurrent Ovarian CarcinomaOvarian CarcinomaRecurrent Ovarian CancerRecurrent Ovarian CarcinomaOvarian CancerNCT02083536University of Miami
已完成
1 期
Safety Study of Sterile Compound C31510 for Injection to Subjects with Solid TumorsSolid TumorsNCT01251562BPGbio50