Aspirin Esomeprazole Chemoprevention Trial

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN85156844
• Date of registration: 15/02/2005
• Primary sponsor: The University of Oxford (UK)
• Public title: Aspirin Esomeprazole Chemoprevention Trial AspECT
• Scientific title: A phase III, randomised, study of Aspirin and Esomeprazole Chemoprevention in Barrett's Metaplasia (BM)
• Date of first enrolment: Mar 1 2005
• Target sample size: Target number of participants as of 22/05/2007: 5500 (5000 male, 500 female). Target number of participants provided at time of registration: 5000
• Recruitment status: Ongoing/Recruiting
• URL: http://isrctn.org/ISRCTN85156844
• Study type: Interventional
• Study design: Phase III, multi-centre, randomised controlled trial.

Countries of recruitment

United Kingdom

Contacts

• Name: Janusz Jankowski

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria amdended as of 22/05/2007:
1. Patients aged over 18 years
2. Patient with circumferential Barrett?s Metaplasia at least 1 cm long, and histologically proven intestinal metaplasia in at least one sample
3. Patient?s able to give written consent
4. Patient?s with World Health Organization (WHO) activity profile of 0 or 1 i.e. fully active and self-caring

Inclusion criteria provided at time of registration:
1. Male between 40 - 75 years
2. At least 2 cm from the gastro-oesophageal junction of circumferential BM (histologically proven by intestinal metaplasia in at least one sample)
3. Able to give written consent
4. World Health Organization (WHO) activity profile of 0 i.e. fully active and self-caring
Exclusion criteria: Exclusion criteria amended as of 22/05/2007:
1. Patients with high grade dysplasia or carcinoma at enrolment;
2. Patients with medical conditions which would make completing endoscopies or the trial difficult to complete including:
2.1. Previous transient ischaemic attacks or cerebral vascular disease
2.2. Severe respiratory disease
2.3. Severe ischaemic heart disease or myocardial infarction in the previous 6 months
2.4. Inflammatory bowel disease
3. Patients who are on continuous aspirin or non-steroidal anti-inflammatories or Cox-2 inhibitors (more than 3 courses/year)
4. Patient?s with absolute contraindications to PPIs, aspirin or their excipients such as allergies, ulcers, renal impairment or use of oral anticoagulants
5. Pregnant or lactating women

Exclusion criteria provided at time of registration:
1. High grade dysplasia or carcinoma at enrolment
2. Medical conditions which would make endoscopy or the trial difficult or failure to complete including transient ischaemic attacks or cerebral vascular disease, severe respiratory disease, severe ischaemic heart disease or recent myocardial infarction or inflammatory bowel disease
3. Patients who are on continuous aspirin or non-steroidal drugs (more than 3 courses/year)
4. Absolute contraindications (ulcers) or allergies to PPIs or aspirin such as renal impairment and oral anticoagulants

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Barrett's oesophagus due to chronic reflux in the gullet

Intervention(s)

Please note that the doses of the drugs below were added as of 22/05/2007:

Arm A (Standard Therapy): 20 mg esomeprazole
Arm B (Strong Acid Suppression): 80 mg esomeprazole
Arm C (Standard Therapy + Aspirin): 20 mg esomeprazole + 300 mg aspirin
Arm D (Strong Acid Suppression + Aspirin): 80 mg esomeprazole + 300 mg aspirin

Please note that as of 22/05/2007 the anticipated start and end dates of this trial have been updated as follows:
Anticipated start of recruitment date: 01/03/2005
Anticipated end of recruitment date: 31/03/2009
Anticipated end of follow-up date: 31/10/2018

The previous anticipated end date of this trial was 01/03/2007.

Primary Outcome(s)

Primary outcome measures added as of 22/05/2007:
The following will be assessed at 4 and 8 years and four yearly until the end of study:
1. Conversion to adenocarcinoma of the oesophagus
2. Conversion to high grade dysplasia
3. Death by all causes

Secondary Outcome(s)

Secondary outcome measures amended as of 20/06/2007:
The following will be assessed at 4 and 8 years and four yearly until the end of study:
1. Incidence of oesophagectomy
2. Stage of adenocarcinoma
3. Incidence of ablation therapy
4. Incidence of endoscopic mucosal resection
5. Quality of life, assessed by The Reflux Disease Questionnaire and the Euroqol-5 Dimensions (EQ-5D) Questionnaire
6. Molecular endpoints including genotype and mutational status

Secondary outcome measures added as of 22/05/2007:
1. Oesophagectomy
2. Stage of adenocarcinoma
3. Ablation therapy
4. Endoscopic mucosal resection

Secondary ID(s)

N/A

NCT00357682

Source(s) of Monetary Support

Cancer Research UK (CRUK) (UK)

Secondary Sponsor(s)

N/A