A Phase III, Randomized, Study of Aspirin and Esomeprazole Chemoprevention in Barrett's Metaplasia

NCT00357682 | Completed Phase 3 Results DMC

• 4 other identifiers: CDR0000491649OCTO-0032004-003836-77ISRCTN85156844
• Study Type: interventional
• Target: 2,557
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of esomeprazole and aspirin may prevent esophageal cancer in patients with Barrett's metaplasia. It is not yet known whether esomeprazole is more effective with or without aspirin in preventing esophageal cancer in patients with Barrett's metaplasia. PURPOSE: This randomized phase III trial is studying esomeprazole with or without aspirin to compare how well they work in preventing esophageal cancer in patients with Barrett's metaplasia.

Conditions

Esophageal Cancer; Precancerous Condition

Keywords

esophageal cancer; Barrett's esophagus

Outcome Measures

Primary Outcomes (1)

• First Event of Death, Oesophageal Adenocarcinoma, High Grade Dysplasia

  Death is recorded on a continuous basis through reporting from trial sites. Oesophageal adenocarcinoma is recorded through endoscopies taken every two years or ad-hoc at clinician decision High Grade Dysplasia is recorded through endoscopies taken every two years or ad-hoc at clinician decision

  Events are assessed from the date of randomisation to the end of study which can be patient withdrawal, loss to follow up or study end (8 years or 10 years from randomisation, depending on consent)

Secondary Outcomes (3)

• All Cause Mortality

  Through study completion, an average of 8.9 years.

• Adenocarcinoma Oesophageal Cancer

  Assessed every 2 years through study completion, an average of 8.9 years

• High Grade Dysplasia

  High Grade Dysplasia is assessed every two years through study completion, an average of 8.9 years.

Study Arms (4)

Arm A

EXPERIMENTAL

20mg Esomeprazole

Drug: Esomeprazole

Arm B

EXPERIMENTAL

80mg Esomeprazole

Drug: Esomeprazole

Arm C

EXPERIMENTAL

20mg Esomeprazole + 300mg Aspirin

Drug: Esomeprazole; Drug: Aspirin

Arm D

EXPERIMENTAL

80mg Esomeprazole + 300mg Aspirin

Drug: Esomeprazole; Drug: Aspirin

Interventions

Esomeprazole DRUG

20mg per day

Also known as: Nexium

Arm A; Arm C

Aspirin DRUG

300mg per day

Arm C; Arm D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 informed consent.
• WHO performance status of 0 or 1 i.e. fully active and self-caring.

You may not qualify if:

• High grade dysplasia or carcinoma at enrolment.
• Medical conditions which would make completing endoscopies or completing the trial difficult including:
• Frequent transient ischaemic attacks (3 or more) or severe cerebral vascular accident in the previous 6 months\*
• Severe respiratory disease with arterial oxygen saturation less 90% at rest
• Severe ischaemic heart disease (exercise tolerance less than 100 yards or life expectancy \< 4 years) or myocardial infarction in the previous 3 months
• 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
• Continuous/frequent non-steroidal anti-inflammatory drug use or COX-2 inhibitors (more than 60 days per year in total).
• 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. This should be discussed with the Trial Office.

Sponsors & Collaborators

• University of Oxford: lead
• AstraZeneca: collaborator

Related Publications (1)

• Jankowski JAZ, de Caestecker J, Love SB, Reilly G, Watson P, Sanders S, Ang Y, Morris D, Bhandari P, Brooks C, Attwood S, Harrison R, Barr H, Moayyedi P; AspECT Trial Team. Esomeprazole and aspirin in Barrett's oesophagus (AspECT): a randomised factorial trial. Lancet. 2018 Aug 4;392(10145):400-408. doi: 10.1016/S0140-6736(18)31388-6. Epub 2018 Jul 26.

  PMID: 30057104 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms; Precancerous Conditions; Barrett Esophagus

Interventions

Esomeprazole; Aspirin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Prof Janusz A Z Jankowski
• Organization: NICE

prof.jankowski@outlook.com

07968 479355

Study Officials

• Janusz Jankowski, MD

  National Institute for Health and Care Excellence

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2006
• First Posted: July 27, 2006
• Study Start: March 10, 2005
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: May 1, 2025
• Results First Posted: May 1, 2025

Record last verified: 2018-08