Title

AspECT

Chief Investigator: 
Janusz Jankowski

EudraCT number: 2004-003836-77
Sponsor: University of Oxford
Funded by: Cancer Research UK
Esomeprazole supplied by: Astra Zeneca

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.

Study Status

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

Study Schema

ARM A: 20mg PPI

= symptomatic treatment only

standard therapy control arm

Arm B: 80mg PPI

strong acid suppression arm

No Aspirin

(A&B)

Arm C: 20mg PPI

symptomatic treatment and aspirin arm

ARM D: 80mg PPI

strong acid suppression and aspirin arm

Aspirin (C&D)
Low dose PPI (A&C) High dose PPI (B&D)  

Inclusion Criteria

  • Aged ≥18 years
  • Circumferential Barrett’s Metaplasia of at least 1cm in length (≥C1M1), or a tongue of Barrett’s metaplasia of at least 2cm in length (≥C0M2) (irrespective of the presence now or historically of histologically proven intestinal metaplasia)
  • Able to give written consent
  • WHO performance status of 0 or 1 i.e. fully active and self-caring

Exclusion Criteria

  • High grade dysplasia or carcinoma at enrolment.
  • Medical conditions which would make completing endoscopies or completing the trial difficult including:
a.       Frequent transient ischaemic attacks (3 or more) or severe cerebral vascular accident in the previous 6 months*
b.      Severe respiratory disease with arterial oxygen saturation less 90% at rest
c.       Severe ischaemic heart disease (exercise tolerance less than 100 yards or life expectancy < 4 years) or myocardial infarction in the previous 3 months
d.      Severe inflammatory bowel disease requiring at least one hospital admission of 5 days in the last year or bowels open > 6 times/day
  • Patients answering yes to criterion a. were eligible for the PPI-only (non-aspirin) arms of the trial.
  • Patients with absolute contraindications to PPIs, aspirin or their excipients i.e. allergies, ulcers, renal impairment or use of oral anticoagulants.
  • Pregnant or lactating women will not undergo endoscopy and may be given dispensation to stop drug therapy for a year

Study Objectives

To 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

Key Dates

Accrual now complete
First interim analysis: 2011
Second interim analysis: 2013
Final analysis and publication: 2018
Trial duration: 10 years

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