Endoscopy Every 2 Years or Only as Needed in Monitoring Patients With Barrett Esophagus
Conditions
Esophageal Cancer - Precancerous Condition
Conditions: official terms
Barrett Esophagus - Esophageal Neoplasms - Precancerous Conditions
Conditions: Keywords
esophageal cancer, adenocarcinoma of the esophagus, Barrett esophagus
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Masking: Open Label, Primary Purpose: Screening
Intervention
Name: questionnaire administration Type: Other
Name: comparison of screening methods Type: Procedure
Name: diagnostic endoscopic procedure Type: Procedure
Name: endoscopic biopsy Type: Procedure
Name: endoscopic procedure Type: Procedure
Name: quality-of-life assessment Type: Procedure
Name: screening method Type: Procedure
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Gloucestershire Royal Hospital
Gloucester, England, United Kingdom
Status: Recruiting
Contact: Hugh Barr - 44-8454-225-460
Start Date
March 2009
Sponsors
Gloucestershire Royal Hospital
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page