A Phase III, Randomized, Study of Aspirin and Esomeprazole Chemoprevention in Barrett's Metaplasia
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 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 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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
Conversion of Barrett's esophagus to adenocarcinoma of the esophagus or high-grade dysplasia
assessed every 2 years
No
Janusz Jankowski, MD
Principal Investigator
Queen Mary University of London
United Kingdom: Medicines and Healthcare Products Regulatory Agency
CDR0000491649
NCT00357682
March 2005
March 2019
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