NCT01243398已完成3 期
Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gefitinib (Iressa®) Versus Placebo in Esophageal Cancer Progressing After Chemotherapy
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether gefitinib is more effective than a placebo in treating esophageal cancer.
PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared with a placebo in treating patients with esophageal cancer that is progressing after chemotherapy.
详细描述
OBJECTIVES:
Primary
- To assess whether gefitinib vs placebo will improve overall survival of patients with esophageal or gastroesophageal junction cancer.
Secondary
- To assess the toxicity of gefitinib monotherapy in these patients.
- To assess whether gefitinib vs placebo will have a significant positive or negative impact upon quality of life of these patients.
- To assess the impact gefitinib vs placebo will have on progression-free survival of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Overall survival
时间窗: 4, 8, 12, 16 weeks then every 8 weeks
次要结局
- Toxicity and safety(4, 8, 12, 16 weeks then every 8 weeks)
- Quality of life(4, 8 and 12 weeks)
- Progression-free survival(4, 8, 12, 16 weeks then every 8 weeks)
研究者
研究点 (2)
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