A phase III, randomised study of aspirin and esoprazole chemoprevention in Barrett's metaplasia.
EudraCT number: 2004-003836-77
Chief Investigator: Prof Janusz Jankowski
Sponsor: University of Oxford
Funded by: Cancer Research UK
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.
Click <here> for list of participating sites
- Aged ≥18 years
- Circumferential Barrett’s Metaplasia of at least 1cm in length, or non-circumferential Barrett's of 2cm or more in length
- Past history of intestinal metaplasia
- Able to give written consent
- WHO performance status of 0 or 1 i.e. fully active and self-caring
- If already prescribed aspirin, or are aspirin intolerant, then randomised to Arm A or B only
- High grade dysplasia or carcinoma at enrolment
- Medical conditions which would make completing endoscopies or completing the trial difficult including
- Previous transient ischaemic attacks or cerebral vascular disease
- Severe respiratory disease
- Severe ischaemic heart disease or myocardial infarction in the previous 6 months
- Inflammatory bowel disease
- Continuous non-steroidal anti-inflammatories or COX-2 inhibitors (more than 60 days per year)
- Patients with absolute contraindications to PPIs or their excipients i.e. allergies, ulcers, renal impairment or use of oral anticoagulants
- Pregnant or lactating women
STUDY OBJECTIVESTo assess whether intervention with aspirin results in decreased mortality or conversion rate from Barrett’s metaplasia to adenocarcinoma or high grade dysplasia.
To assess whether high dose PPI therapy decreases mortality or conversion rate from Barrett’s Metaplasia to adenocarcinoma or high grade dysplasia
Accrual now complete
First interim analysis: 2011
Second interim analysis: 2013
Final analysis and publication: 2017
Trial duration: 8 years