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

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ClinicalTrials.gov Identifier: NCT00357682
Recruitment Status : Unknown
Verified May 2016 by University of Oxford.
Recruitment status was:  Active, not recruiting
First Posted : July 27, 2006
Last Update Posted : May 18, 2016
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
University of Oxford

Study Description
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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.


Condition or disease Intervention/treatment Phase
Esophageal Cancer Precancerous Condition Drug: Esomeprazole Drug: Aspirin Phase 3

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 will be made to CRUK 18 months before the end of the current grant.

A total of 2513 patients have been accrued for this study. They remain on trial medication and follow up.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2513 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase III, Randomized, Study of Aspirin and Esomeprazole Chemoprevention in Barrett's Metaplasia
Study Start Date : March 2005
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A
20mg Esomeprazole
 Drug: Esomeprazole
20mg per day
Other Name: Nexium
Experimental: Arm B
80mg Esomeprazole
 Drug: Esomeprazole
80mg per day
Other Name: Nexium
Experimental: Arm C
20mg Esomeprazole + 300mg Aspirin
 Drug: Esomeprazole
20mg per day
Other Name: Nexium

Drug: Aspirin
300mg per day
Experimental: Arm D
80mg Esomeprazole + 300mg Aspirin
 Drug: Esomeprazole
80mg per day
Other Name: Nexium

Drug: Aspirin
300mg per day


Outcome Measures
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Primary Outcome Measures :
  1. Conversion of Barrett's esophagus to adenocarcinoma of the esophagus or high-grade dysplasia [ Time Frame: assessed every 2 years ]

Secondary Outcome Measures :
  1. All causes of mortality [ Time Frame: assessed annually ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  1. Aged ≥18 years.
  2. 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).
  3. Able to give written informed consent.
  4. WHO performance status of 0 or 1 i.e. fully active and self-caring.

EXCLUSION CRITERIA

  1. High grade dysplasia or carcinoma at enrolment.

  2. Medical conditions which would make completing endoscopies or completing the trial difficult including:

    1. Frequent transient ischaemic attacks (3 or more) or severe cerebral vascular accident in the previous 6 months*
    2. Severe respiratory disease with arterial oxygen saturation less 90% at rest
    3. Severe ischaemic heart disease (exercise tolerance less than 100 yards or life expectancy < 4 years) or myocardial infarction in the previous 3 months
    4. 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
  3. Continuous/frequent non-steroidal anti-inflammatory drug use or COX-2 inhibitors (more than 60 days per year in total).
  4. Patients with absolute contraindications to PPIs, aspirin or their excipients i.e. allergies, ulcers, renal impairment or use of oral anticoagulants.
  5. 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357682


Sponsors and Collaborators
University of Oxford
AstraZeneca
Investigators
Principal Investigator: Janusz Jankowski, MD Queen Mary University of London
More Information
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT00357682     History of Changes
Other Study ID Numbers: CDR0000491649
OCTO-003 ( Other Identifier: Oncology Clinical Trials Office )
2004-003836-77 ( EudraCT Number )
ISRCTN85156844 ( Registry Identifier: ISRCTN )
First Posted: July 27, 2006    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by University of Oxford:
esophageal cancer
Barrett's esophagus

Additional relevant MeSH terms:
Esophageal Neoplasms
Metaplasia
Precancerous Conditions
Barrett Esophagus
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Pathologic Processes
Digestive System Abnormalities
Aspirin
 Esomeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors