Esophageal CancerPhase 3AspECTNCT00357682

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

A Phase 3 study testing Esomeprazole and Aspirin in people with Esophageal Cancer and Precancerous Condition, run by University of Oxford.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Esophageal Cancer, Precancerous Condition
What is being tested?: Esomeprazole and Aspirin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,557 participants
Where: No sites listed yet
Study dates: 10 Mar 2005to 31 May 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

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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.
If a patient was suitable for inclusion but later becomes unsuitable this should be discussed with the Trial Office before they are withdrawn. Only in exceptional circumstances should patients not be followed up i.e. withdrawal of consent or current life threatening disease with poor outcome and therefore unable to tolerate endoscopy. In these circumstances patients should be followed up in outpatient clinics.

About this study

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.

Read the detailed description

PRIMARY OBJECTIVES

To assess whether intervention with aspirin results in a decreased rate of all causes of mortality or conversion rate from Barrett's metaplasia to adenocarcinoma or high grade dysplasia.
To assess whether high dose PPI (protein pump inhibitor) therapy results in a decreased rate of all causes of mortality or conversion rate from Barrett's metaplasia to adenocarcinoma or high grade dysplasia.

SECONDARY OBJECTIVES

To assess whether intervention with aspirin results in decreased high-grade dysplasia, in decreased all cause mortality, in decreased oesophageal cancer incidence and in decreased cause-specific mortality when each is considered separately
To assess whether intervention with high dose PPI results in decreased high-grade dysplasia, in decreased all cause mortality, in decreased oesophageal cancer incidence and in decreased cause-specific mortality when each is considered separately
To assess whether there are clinical and molecular risk factors which can be identified in BM (Barrett's Metaplasia) for the development of BA.
To assess the cost effectiveness of aspirin and/or PPI treatment in the prevention of BA.
To assess whether intervention with PPI and/or aspirin induces changes in the expression of molecular markers for BA.
To investigate new genes important in the progression of BA, as a unique tissue bank will be available with a complete endoscopic, histological, physiology and pharmaceutical history.
To assess inherited genetic factors for predisposition to oesophagitis above BM, BM, LGD HGD and BA.
To assess what the biological risk factors are for cardiac disease and aspirin resistance.
To assess gender differences in outcomes.

Cancer Research UK approved the study in 2003 for a 10 year period to run from 1st January 2005 to 31st December 2014. Funding is renewable annually and is dependent on a satisfactory review by an independent committee.

An application for a funding extension was made to CRUK 18 months before the end of the grant and the funding was extended to 31Aug2018.

A total of 2557 patients have been accrued for this study in the UK.

Conditions: Esophageal Cancer, Precancerous Condition
Being tested: Esomeprazole, Aspirin
Keywords: esophageal cancer, Barrett's esophagus
Medical subject headings: Esophageal Neoplasms, Precancerous Conditions, Barrett Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EsomeprazoleDrug
Also called Nexium
20mg per day
EsomeprazoleDrug
Also called Nexium
80mg per day
AspirinDrug
300mg per day

Study groups in NCT00357682
Study group	Role	What they receive
Arm A	Experimental	20mg Esomeprazole Receives: Drug: Esomeprazole
Arm B	Experimental	80mg Esomeprazole Receives: Drug: Esomeprazole
Arm C	Experimental	20mg Esomeprazole + 300mg Aspirin Receives: Drug: Esomeprazole; Drug: Aspirin
Arm D	Experimental	80mg Esomeprazole + 300mg Aspirin Receives: Drug: Esomeprazole; Drug: Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Accelerated Failure Time (AFT) analysis comparing time to all cause mortality in low dose PPI (20mg) patients to high dose PPI (80mg) patients and in aspirin patients to non-aspirin patients. Included in AFT model are stratification factors (Barrett's length, age group and presence of baseline intestinal metaplasia) and aspirin randomisation group.
Measured: Through study completion, an average of 8.9 years.
Adenocarcinoma Oesophageal Cancer
Number of aspirin and non-aspirin patients and low dose PPI and high dose PPI patients with adenocarcinoma oesophageal cancer
Measured: Assessed every 2 years through study completion, an average of 8.9 years
High Grade Dysplasia
Diagnosis of high grade dysplasia is compared in aspirin and non-aspirin trial patients, and in high dose PPI and low dose PPI patients.
Measured: High Grade Dysplasia is assessed every two years through study completion, an average of 8.9 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 200531 May 2017

First posted27 Jul 2006 (estimated)
Study start10 Mar 2005
Primary completion31 May 2017
Study completion31 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Esophageal CancerStudies of the same condition, open and under way.
More trials run by University of OxfordThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 2,557 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00357682
Sponsor's protocol ID: CDR0000491649
Other IDs: OCTO-003, 2004-003836-77, ISRCTN85156844, 2004
Acronym: AspECT
Status last verified: Aug 2018
First submitted: 26 Jul 2006
Last updated: 1 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 30057104

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Esophageal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Study of Aspirin and Esomeprazole Chemoprevention in Barrett's Metaplasia
ClinicalTrials.gov ID: NCT00357682
Acronym / sponsor ID: AspECT / CDR0000491649
Conditions: Esophageal Cancer, Precancerous Condition
Keywords: esophageal cancer, Barrett's esophagus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,557 participants (actual)
Lead sponsor: University of OxfordUniversity, hospital or other
Collaborators: AstraZeneca
Study start: 10 Mar 2005 (actual)
Primary completion: 31 May 2017 (actual)
Study completion: 31 May 2017 (actual)
First posted: 27 Jul 2006 (estimated)
Results: Posted 1 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

PRIMARY OBJECTIVES

To assess whether intervention with aspirin results in a decreased rate of all causes of mortality or conversion rate from Barrett's metaplasia to adenocarcinoma or high grade dysplasia.
To assess whether high dose PPI (protein pump inhibitor) therapy results in a decreased rate of all causes of mortality or conversion rate from Barrett's metaplasia to adenocarcinoma or high grade dysplasia.

SECONDARY OBJECTIVES

To assess whether intervention with aspirin results in decreased high-grade dysplasia, in decreased all cause mortality, in decreased oesophageal cancer incidence and in decreased cause-specific mortality when each is considered separately
To assess whether intervention with high dose PPI results in decreased high-grade dysplasia, in decreased all cause mortality, in decreased oesophageal cancer incidence and in decreased cause-specific mortality when each is considered separately
To assess whether there are clinical and molecular risk factors which can be identified in BM (Barrett's Metaplasia) for the development of BA.
To assess the cost effectiveness of aspirin and/or PPI treatment in the prevention of BA.
To assess whether intervention with PPI and/or aspirin induces changes in the expression of molecular markers for BA.
To investigate new genes important in the progression of BA, as a unique tissue bank will be available with a complete endoscopic, histological, physiology and pharmaceutical history.
To assess inherited genetic factors for predisposition to oesophagitis above BM, BM, LGD HGD and BA.
To assess what the biological risk factors are for cardiac disease and aspirin resistance.
To assess gender differences in outcomes.

An application for a funding extension was made to CRUK 18 months before the end of the grant and the funding was extended to 31Aug2018.

A total of 2557 patients have been accrued for this study in the UK.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Arm A	Experimental	Drug: Esomeprazole20mg Esomeprazole
Arm B	Experimental	Drug: Esomeprazole80mg Esomeprazole
Arm C	Experimental	Drug: Esomeprazole, Drug: Aspirin20mg Esomeprazole + 300mg Aspirin
Arm D	Experimental	Drug: Esomeprazole, Drug: Aspirin80mg Esomeprazole + 300mg Aspirin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (10 listed)

High grade dysplasia or carcinoma at enrolment.
Medical conditions which would make completing endoscopies or completing the trial difficult including:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EsomeprazoleAlso: Nexium20mg per day	Drug	Arm A, Arm C
EsomeprazoleAlso: Nexium80mg per day	Drug	Arm B, Arm D
Aspirin300mg per day	Drug	Arm C, Arm D

Primary outcome

First Event of Death, Oesophageal Adenocarcinoma, High Grade Dysplasia
Time frame: 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)
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

3 secondary outcomes

All Cause Mortality
Time frame: Through study completion, an average of 8.9 years.
Adenocarcinoma Oesophageal Cancer
Time frame: Assessed every 2 years through study completion, an average of 8.9 years
High Grade Dysplasia
Time frame: High Grade Dysplasia is assessed every two years through study completion, an average of 8.9 years.

Results and safety

Results posted to the registry on 1 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A	705	364
Arm B	704	394
Arm C	571	320
Arm D	577	312

Primary outcome: First Event of Death, Oesophageal Adenocarcinoma, High Grade Dysplasia

Time frame: 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). Count of participants. Unit: Participants

Measure	Aspirin n = 1138	No Aspirin n = 1142	Low Dose PPI n = 1265	High Dose PPI n = 1270
Value	127	154	174	139

Low Dose PPI vs High Dose PPI: Time Ratio: 1.24 (95% CI 0.98 to 1.57), p = 0.068, Accelerated Failure Time
Aspirin vs No Aspirin: Time Ratio: 1.27 (95% CI 1.01 to 1.58), p = 0.037, Accelerated Failure Time

Population analysed: Intent to treat population

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event monitoring started from the time the patient commenced study medication until 30 days after stopping trial medication (an average of 8.9 years).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aspirin	340 of 1,138 (29.9%)	0 of 1,138 (0%)	73 of 1,138
No Aspirin	378 of 1,142 (33.1%)	0 of 1,142 (0%)	90 of 1,142
Low Dose PPI	359 of 1,265 (28.4%)	0 of 1,265 (0%)	105 of 1,265
High Dose PPI	359 of 1,270 (28.3%)	0 of 1,270 (0%)	79 of 1,270

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30057104Jankowski 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.
Individual participant dataSharing planned: Undecided

Related trials for Esophageal Cancer

Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 2
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
Advanced Solid Tumor, Melanoma
RecruitingPhase 2/3
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janusz Jankowski, MD principal investigator

National Institute for Health and Care Excellence

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Esomeprazole and Aspirin in people with Esophageal Cancer and Precancerous Condition, run by University of Oxford.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First Event of Death, Oesophageal Adenocarcinoma, High Grade Dysplasia (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00357682, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.