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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00987857
• Other study ID #: NHS-GRH-HTA-05/12/01
• Secondary ID: CDR0000649890ISR
• Status: Active, not recruiting
• Phase: N/A
• First received: September 30, 2009
• Last updated: August 17, 2017
• Start date: March 2009
• Est. completion date: May 2022

Study information

• Verified date: August 2017
• Source: Gloucestershire Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3400
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Cancer
• Esophageal Neoplasms
• Precancerous Condition
• Precancerous Conditions

Intervention

Procedure:
• 2 yearly endoscopy
2 yearly endoscopy versus endoscopy at need
• comparison of screening methods
2 yearly endoscopy versus endoscopy at need
• diagnostic endoscopic procedure
2 yearly endoscopy versus endoscopy at need
• endoscopic biopsy
2 yearly endoscopy versus endoscopy at need
• endoscopic procedure
2 yearly endoscopy versus endoscopy at need
• quality-of-life assessment
QOL aims to elicit any differences in QOL between 2 yearly endoscopy versus endoscopy at need
• screening method
All Barretts patients to be screened

Locations

Country	Name	City	State
United Kingdom	Gloucestershire Royal Hospital	Gloucester	England

Sponsors (1)

Lead Sponsor	Collaborator
Gloucestershire Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival
Secondary	Cost-effectiveness
Secondary	Incidence of esophageal cancer, gastric or esophageal cancer, or all cancers
Secondary	Time to diagnosis of esophageal adenocarcinoma
Secondary	Stage of esophageal adenocarcinoma at diagnosis using TNM staging
Secondary	Morbidity and mortality related to endoscopy, esophageal surgery, and other endoscopy-related interventions
Secondary	Frequency of endoscopy