A Phase III, Randomized, Study of Aspirin and Esomeprazole Chemoprevention in Barrett's Metaplasia
- Conditions
- Esophageal CancerPrecancerous Condition
- Interventions
- Registration Number
- NCT00357682
- Lead Sponsor
- University of Oxford
- Brief Summary
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.
- Detailed Description
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.
An application for a funding extension will be made to CRUK 18 months before the end of the current grant.
A total of 2513 patients have been accrued for this study. They remain on trial medication and follow up.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2513
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Arm A Esomeprazole 20mg Esomeprazole Arm B Esomeprazole 80mg Esomeprazole Arm C Aspirin 20mg Esomeprazole + 300mg Aspirin Arm C Esomeprazole 20mg Esomeprazole + 300mg Aspirin Arm D Esomeprazole 80mg Esomeprazole + 300mg Aspirin Arm D Aspirin 80mg Esomeprazole + 300mg Aspirin
- Primary Outcome Measures
Name Time Method Conversion of Barrett's esophagus to adenocarcinoma of the esophagus or high-grade dysplasia assessed every 2 years
- Secondary Outcome Measures
Name Time Method All causes of mortality assessed annually