Endoscopy Every 2 Years or Only as Needed in Monitoring Patients With Barrett Esophagus

Study Overview
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Brief Summary
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RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment. It is not yet known whether endoscopy every 2 years is more effective than endoscopy only as needed in finding esophageal cancer in patients with Barrett esophagus. PURPOSE: This randomized phase III trial is studying endoscopy every 2 years to see how well it works compared with endoscopy only as needed in monitoring patients with Barrett esophagus.

Detailed Description
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OBJECTIVES: Primary To establish whether endoscopic surveillance every 2 years or endoscopy at need only is superior in terms of overall survival and, if neither is superior, whether endoscopy at need only is non-inferior to surveillance every 2 years in patients with Barrett esophagus. Secondary To estimate the cost-effectiveness of endoscopic surveillance every 2 years as compared to endoscopy at need only. To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the incidence of esophageal cancer, gastric or esophageal cancer, or all cancers. To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the time to diagnosis of esophageal adenocarcinoma. To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the stage of esophageal adenocarcinoma at diagnosis using TNM staging. To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of morbidity and mortality related to endoscopy, esophageal surgery, and other endoscopy-related interventions (e.g., ablation). To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the frequency of endoscopy. OUTLINE: This is a multicenter study. Patients are stratified according to age at diagnosis (< 65 years vs ≥ 65 years), length of Barrett metaplasia segment including tongues (< 2 cm vs ≥ 2 cm and ≤ 3 cm vs > 3 cm and ≤ 8 cm vs > 8 cm), and newly diagnosed disease (defined as the date of endoscopy confirming Barrett metaplasia was within the past 4 months) (yes vs no). Patients are randomized to 1 of 2 intervention arms. Arm I: Patients undergo surveillance endoscopy with quadrantic biopsies taken every 2 cm. Patients undergo endoscopy every 2 years for a total of 6 endoscopies over 10 years. Arm II: Patients undergo endoscopy as needed over 10 years. All patients may undergo urgent endoscopy if they develop dysphagia, unexplained weight loss of > 7 lb, iron-deficiency anemia, recurrent vomiting, or worsening upper gastrointestinal symptoms. All patients complete a questionnaire that includes a quality-of-life measure and questions about medication at baseline, every 2 years, and following key events (e.g., diagnosis of any cancer or high-grade dysplasia).

Official Title
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Barrett's Oesophagus Two Yearly Surveillance Versus Endoscopy at Need: a Randomised Controlled Trial to Estimate Effectiveness and Cost-effectiveness Study (BOSS)

Conditions
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Esophageal Cancer, Precancerous Condition

Intervention / Treatment
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* Procedure: 2 yearly endoscopy
* Procedure: comparison of screening methods
* Procedure: diagnostic endoscopic procedure
* Procedure: endoscopic biopsy
* Procedure: endoscopic procedure
* Procedure: quality-of-life assessment
* Procedure: screening method


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed circumferential Barrett metaplasia meeting 1 of the following criteria: At least 1 cm from the gastro-esophageal junction At least a 2 cm non-circumferential tongue of Barrett metaplasia Undergone endoscopy within the last 2 years to confirm Barrett metaplasia and exclude high-grade dysplasia and carcinoma No known high-grade dysplasia or carcinoma PATIENT CHARACTERISTICS: Resident of the United Kingdom Informed of the risk of Barrett esophagus developing into esophageal cancer, either at the visit when the invitation letter is issued or on a documented previous occasion Able to undergo endoscopy No medical conditions that would make endoscopy difficult or hazardous PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2 yearly endoscopies<br>Two years endoscopies | Procedure: 2 yearly endoscopy<br>* 2 yearly endoscopy versus endoscopy at need<br>Procedure: comparison of screening methods<br>* 2 yearly endoscopy versus endoscopy at need<br>Procedure: diagnostic endoscopic procedure<br>* 2 yearly endoscopy versus endoscopy at need<br>Procedure: endoscopic biopsy<br>* 2 yearly endoscopy versus endoscopy at need<br>Procedure: endoscopic procedure<br>* 2 yearly endoscopy versus endoscopy at need<br>Procedure: quality-of-life assessment<br>* QOL aims to elicit any differences in QOL between 2 yearly endoscopy versus endoscopy at need<br>Procedure: screening method<br>* All Barretts patients to be screened<br>|
| Experimental: endoscopy at need<br>Endoscopy only when patient reports symptoms | Procedure: 2 yearly endoscopy<br>* 2 yearly endoscopy versus endoscopy at need<br>Procedure: comparison of screening methods<br>* 2 yearly endoscopy versus endoscopy at need<br>Procedure: diagnostic endoscopic procedure<br>* 2 yearly endoscopy versus endoscopy at need<br>Procedure: endoscopic biopsy<br>* 2 yearly endoscopy versus endoscopy at need<br>Procedure: endoscopic procedure<br>* 2 yearly endoscopy versus endoscopy at need<br>Procedure: quality-of-life assessment<br>* QOL aims to elicit any differences in QOL between 2 yearly endoscopy versus endoscopy at need<br>Procedure: screening method<br>* All Barretts patients to be screened<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness |  |  | 
| Incidence of esophageal cancer, gastric or esophageal cancer, or all cancers |  |  | 
| Time to diagnosis of esophageal adenocarcinoma |  |  | 
| Stage of esophageal adenocarcinoma at diagnosis using TNM staging |  |  | 
| Morbidity and mortality related to endoscopy, esophageal surgery, and other endoscopy-related interventions |  |  | 
| Frequency of endoscopy |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal cancer, adenocarcinoma of the esophagus, Barrett esophagus