A Phase III, Randomized, Study of Aspirin and Esomeprazole Chemoprevention in Barrett's Metaplasia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,557
- 主要终点
- First Event of Death, Oesophageal Adenocarcinoma, High Grade Dysplasia
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of esomeprazole and aspirin may prevent esophageal cancer in patients with Barrett's metaplasia. It is not yet known whether esomeprazole is more effective with or without aspirin in preventing esophageal cancer in patients with Barrett's metaplasia.
PURPOSE: This randomized phase III trial is studying esomeprazole with or without aspirin to compare how well they work in preventing esophageal cancer in patients with Barrett's metaplasia.
详细描述
PRIMARY OBJECTIVES
- To assess whether intervention with aspirin results in a decreased rate of all causes of mortality or conversion rate from Barrett's metaplasia to adenocarcinoma or high grade dysplasia.
- To assess whether high dose PPI (protein pump inhibitor) therapy results in a decreased rate of all causes of mortality or conversion rate from Barrett's metaplasia to adenocarcinoma or high grade dysplasia.
SECONDARY OBJECTIVES
- To assess whether intervention with aspirin results in decreased high-grade dysplasia, in decreased all cause mortality, in decreased oesophageal cancer incidence and in decreased cause-specific mortality when each is considered separately
- To assess whether intervention with high dose PPI results in decreased high-grade dysplasia, in decreased all cause mortality, in decreased oesophageal cancer incidence and in decreased cause-specific mortality when each is considered separately
- To assess whether there are clinical and molecular risk factors which can be identified in BM (Barrett's Metaplasia) for the development of BA.
- To assess the cost effectiveness of aspirin and/or PPI treatment in the prevention of BA.
- To assess whether intervention with PPI and/or aspirin induces changes in the expression of molecular markers for BA.
- To investigate new genes important in the progression of BA, as a unique tissue bank will be available with a complete endoscopic, histological, physiology and pharmaceutical history.
- To assess inherited genetic factors for predisposition to oesophagitis above BM, BM, LGD HGD and BA.
- To assess what the biological risk factors are for cardiac disease and aspirin resistance.
- To assess gender differences in outcomes.
Cancer Research UK approved the study in 2003 for a 10 year period to run from 1st January 2005 to 31st December 2014. Funding is renewable annually and is dependent on a satisfactory review by an independent committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A
20mg Esomeprazole
干预措施: Esomeprazole (Drug)
Arm B
80mg Esomeprazole
干预措施: Esomeprazole (Drug)
Arm C
20mg Esomeprazole + 300mg Aspirin
干预措施: Esomeprazole (Drug)
Arm C
20mg Esomeprazole + 300mg Aspirin
干预措施: Aspirin (Drug)
Arm D
80mg Esomeprazole + 300mg Aspirin
干预措施: Esomeprazole (Drug)
Arm D
80mg Esomeprazole + 300mg Aspirin
干预措施: Aspirin (Drug)
结局指标
主要结局
First Event of Death, Oesophageal Adenocarcinoma, High Grade Dysplasia
时间窗: Events are assessed from the date of randomisation to the end of study which can be patient withdrawal, loss to follow up or study end (8 years or 10 years from randomisation, depending on consent)
Death is recorded on a continuous basis through reporting from trial sites. Oesophageal adenocarcinoma is recorded through endoscopies taken every two years or ad-hoc at clinician decision High Grade Dysplasia is recorded through endoscopies taken every two years or ad-hoc at clinician decision
次要结局
- Adenocarcinoma Oesophageal Cancer(Assessed every 2 years through study completion, an average of 8.9 years)
- High Grade Dysplasia(High Grade Dysplasia is assessed every two years through study completion, an average of 8.9 years.)
- All Cause Mortality(Through study completion, an average of 8.9 years.)