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

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

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer; Precancerous Condition
• Intervention / Treatment: 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

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 3400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Gloucester, England, United Kingdom, GL1 3NN
      • Gloucestershire Royal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Gloucestershire Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Hugh Barr, Gloucestershire Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: September 30, 2009
• First Submitted That Met QC Criteria: September 30, 2009
• First Posted (Estimate): October 1, 2009

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: esophageal cancer; adenocarcinoma of the esophagus; Barrett esophagus
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Barrett Esophagus; Precancerous Conditions
• Other Study ID Numbers: NHS-GRH-HTA-05/12/01; CDR0000649890 (Registry Identifier: PDQ (Physician Data Query)); ISRCTN54190466