AspECT


A phase III, randomised study of aspirin and esomeprazole chemoprevention in Barrett's metaplasia.

 

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

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

 

EXCLUSION CRITERIA

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
 

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: 2017
Trial duration: 8 years


AspECT Trial Office (OCTO)

General Enquiries: Tel: 01865 617011, Fax: 01865 617010

Email: aspect@octo-oxford.org.uk Website: www.octo-oxford.org.uk

 

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