Clinical trial NCT00987857: Endoscopy Every 2 Years or Only as Needed in Monitoring Patients With Barrett Esophagus
Official title: Barrett's Oesophagus Two Yearly Surveillance Versus Endoscopy at Need: a Randomised Controlled Trial to Estimate Effectiveness and Cost-effectiveness Study (BOSS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Precancerous Condition
Keywords: esophageal cancer
adenocarcinoma of the esophagus
Barrett esophagus
Lead sponsor: Gloucestershire Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-10-01
Enrollment: 3400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: Cost-effectiveness
measure: Incidence of esophageal cancer, gastric or esophageal cancer, or all cancers
measure: Time to diagnosis of esophageal adenocarcinoma
measure: Stage of esophageal adenocarcinoma at diagnosis using TNM staging
measure: Morbidity and mortality related to endoscopy, esophageal surgery, and other endoscopy-related interventions
measure: Frequency of endoscopy
Other outcomes:
Locations:
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
state: England
Study officials:
affiliation: Gloucestershire Hospitals NHS Foundation Trust
name: Hugh Barr
role: PRINCIPAL_INVESTIGATOR
References: