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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00987857
First received: September 30, 2009
Last updated: August 9, 2013
Last verified: September 2009

September 30, 2009
August 9, 2013
March 2009
Not Provided
Overall survival [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00987857 on ClinicalTrials.gov Archive Site
  • Cost-effectiveness [ Designated as safety issue: No ]
  • Incidence of esophageal cancer, gastric or esophageal cancer, or all cancers [ Designated as safety issue: No ]
  • Time to diagnosis of esophageal adenocarcinoma [ Designated as safety issue: No ]
  • Stage of esophageal adenocarcinoma at diagnosis using TNM staging [ Designated as safety issue: No ]
  • Morbidity and mortality related to endoscopy, esophageal surgery, and other endoscopy-related interventions [ Designated as safety issue: No ]
  • Frequency of endoscopy [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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).

Interventional
Phase 3
Allocation: Randomized
Masking: Open Label
Primary Purpose: Screening
  • Esophageal Cancer
  • Precancerous Condition
  • Other: questionnaire administration
  • Procedure: comparison of screening methods
  • Procedure: diagnostic endoscopic procedure
  • Procedure: endoscopic biopsy
  • Procedure: endoscopic procedure
  • Procedure: quality-of-life assessment
  • Procedure: screening method
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2500
Not Provided
Not Provided

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
Both
18 Years and older
No
United Kingdom
 
NCT00987857
NHS-GRH-HTA-05/12/01, CDR0000649890, ISRCTN54190466
Not Provided
Not Provided
Gloucestershire Royal Hospital
Not Provided
Principal Investigator: Hugh Barr Gloucestershire Royal Hospital
National Cancer Institute (NCI)
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP