A phase III, randomised study of aspirin and esomeprazole chemoprevention in Barrett's metaplasia.
The trial is a pragmatic, multicentre, phase III, randomised, open, 2X2 factorial trial. The main aim of the trial is to investigate the benefits of acid suppression with low or high dose esomeprazole with or without aspirin in reducing the risk of cancer in Barrett’s oesophagus. The acid suppression tablet is esomeprazole (Nexium). Since acid reflux is involved in causing Barrett’s oesophagus it has been suggested that reduction of acid to very low levels might prevent progression to cancer. At present it is not known if this is true. There is considerable evidence already that aspirin is effective in preventing cancer of the gastrointestinal tract, including cancers of the stomach and oesophagus.
Closed to recruitment.
AspECT has reached its target of 2500 patients. Patients remain on randomised treatment and trial follow-up.
Click <here> for list of participating sites
ARM A: 20mg PPI
= symptomatic treatment only
standard therapy control arm
Arm B: 80mg PPI
strong acid suppression arm
Arm C: 20mg PPI
symptomatic treatment and aspirin arm
ARM D: 80mg PPI
strong acid suppression and aspirin arm
Low dose PPI (A&C)
High dose PPI (B&D)
Accrual now complete
First interim analysis: 2011
Second interim analysis: 2013
Final analysis and publication: 2018
Trial duration: 10 years