Barrett's Oesophagus Two Yearly Surveillance Versus Endoscopy at Need: a Randomised Controlled Trial to Estimate Effectiveness and Cost-effectiveness Study (BOSS)
| Registry | NCT00987857 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, screening |
| Enrollment | 3400 (Actual) |
| Sponsor | Gloucestershire Hospitals NHS Foundation Trust (Other) |
| Conditions | Esophageal Cancer, Precancerous Condition |
| Interventions | 2 yearly endoscopy, comparison of screening methods, diagnostic endoscopic procedure, endoscopic biopsy, endoscopic procedure, quality-of-life assessment, screening method (Procedure) |
| Dates | start 2009-03-01, primary completion 2022-05-01 (estimated), completion 2022-05-01 (estimated), first posted 2009-10-01, last updated 2017-08-22 |
| Locations | 1 site in United Kingdom |
Related Papers Related Patents Related Grants Related Experts
All trials for Esophageal Cancer All trials for Precancerous Condition All trials of 2 yearly endoscopy All trials of comparison of screening methods
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.
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 2 yearly endoscopies | Active comparator | 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 | Two years endoscopies |
| endoscopy at need | Experimental | 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 | Endoscopy only when patient reports symptoms |
Sex: All, ages: 18 Years to 120 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Gloucestershire Royal Hospital | Gloucester, England | United Kingdom |