AspECT

EudraCT number: 2004-003836-77
Joint Chief Investigators: Dr. John de Caestecker and Prof Janusz Jankowski
Sponsor: University of Oxford

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

Open to recruitment.
Target recruitment: 2500 patients
Current recruitment: 2305 patients (31 December 2008)
AspECT has reached its target of 500 women.

Click <here> for list of participating sites

STUDY SCHEMA

INCLUSION CRITERIA

• 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

EXCLUSION CRITERIA

• 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 OBJECTIVES

KEY DATES

Planned accrual completion: Jan 2009
First interim analysis: 2011
Second interim analysis: 2012
Final analysis and publication: 2016
Trial duration: 8 years

AspECT Trial Office (OCTO)