A Phase IB, Open-Label, Safety Study of the Combination of Sunitinib and Radiation for the Treatment of Patients With Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- To evaluate the safety and toxicity profile of sunitinib when used with concurrent radiation therapy
研究概览
简要总结
This study is using the combination of radiation and antiangiogenic agents (agents that destroy existing blood vessels) seems to be an approach to tumor cure.
详细描述
The combination of ionizing radiation and antiangiogenic agents seems to be a counterintuitive approach to tumor cure because oxygen is a potent radiosensitizer and a reduction in oxygen concentration would be expected following a reduction in tumor vasculature after antiangiogenic treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum 2 week course of radiation therapy
- •Solid tumors of the central nervous system, head and neck, thorax, and pelvis
排除标准
- •Major surgery or radiation therapy within 4 weeks starting study treatment
- •Grade 3 hemorrhage within 4 weeks
研究组 & 干预措施
Sunitinib plus Radiation
Sunitinib plus Radiation
干预措施: Sunitinib (Drug)
Sunitinib plus Radiation
Sunitinib plus Radiation
干预措施: External Beam Radiation Therapy (Radiation)
结局指标
主要结局
To evaluate the safety and toxicity profile of sunitinib when used with concurrent radiation therapy
时间窗: 2 years
The purpose of this study is to determine the safety of the combination of the antiangiogenic, sunitinib, when combined with external beam radiotherapy.
次要结局
- To measure urine VEGF(2 years)