NCT00158041已完成4 期
Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
Mt. Sinai Medical Center, Miami2 个研究点 分布在 1 个国家目标入组 452 人开始时间: 2002年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 452
- 试验地点
- 2
- 主要终点
- Incidence of nausea/vomiting
研究概览
简要总结
Amifostine is a radioprotective drug which is approved by the US FDA for administration prior to each radiation treatment using the intravenous route. The study evaluated the safety of amifostine administered subcutaneously. The four targeted toxicities were nausea/vomiting, hypotension, generalized skin rash, and injection-site skin reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Institutional criteria for administration of amifostine
- •Radiation therapy
- •ECOG PS of at least 2
- •No distant mets
- •Granulocyte count greater than 2000
- •Platelet count greater than 100,000
- •Creatinine less than 2.0
排除标准
- •Allergy to amifostine
- •Life expectancy less than 6 mos
- •Investigational drug within last 4 weeks
结局指标
主要结局
Incidence of nausea/vomiting
Incidence of hypotension
Incidence of generalized skin rash
Incidence of injection-site skin toxicity
次要结局
未报告次要终点
研究者
研究点 (2)
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