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Bending the Curve Trial by Trial
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BOSS

Barrett's Oesophagus Surveillance Versus Endoscopy at Need Study (BOSS): a randomized controlled trial

N = 3,453NCT00987857

Population
Patients with Barrett's oesophagus. The ClinicalTrials.gov record lists histologically confirmed Barrett metaplasia (at least 1 cm circumferential, or a tongue of at least 2 cm) with no known high-grade dysplasia or carcinoma, and residence in the United Kingdom.
Design
Randomised controlled trial at 109 centres in the United Kingdom: 2-yearly surveillance endoscopy versus 'at-need' endoscopy offered for symptoms only. Minimum follow-up 10 years. Primary outcome overall survival (intention-to-treat); secondary outcomes included cancer-specific survival, time to diagnosis of oesophageal adenocarcinoma (EAC), stage at diagnosis and serious adverse events. The abstract reports 3453 patients recruited and 1733 plus 1719 randomised (a total of 3452); ClinicalTrials.gov lists 3400. The registry lists 2-yearly endoscopy as the active comparator and endoscopy at need as the experimental arm; its primary objective tests superiority of either strategy and, if neither is superior, non-inferiority of endoscopy at need.
Primary endpoint
OS
Arms
  • 2-yearly surveillance endoscopy (control, n = 1,733): Surveillance endoscopy every 2 years
  • Endoscopy at need (experimental, n = 1,719): Endoscopy offered for symptoms only
People
Old O
OSHR 0.95 (95% CI 0.82–1.10)
Show the numbers
Results reported for BOSS
EndpointAnalysisEndoscopy at need2-yearly surveillance endoscopyEffect
OSIntention-to-treat populationprimarymedian follow-up 12.8 yearsOld 2025——HR 0.95 (95% CI 0.82–1.10)P=0.503333 deaths among 1733 patients (surveillance) vs 356 among 1719 (at need). The abstract states no evidence of a difference. Cancer-specific survival: 108 vs 106 deaths from any cancer (HR 1.01, 95% CI 0.77 to 1.33; P=.926). Time to diagnosis of EAC: 40 vs 31 patients diagnosed (HR 1.32, 95% CI 0.82 to 2.11; P=.254). Serious adverse events related to interventions: 8 (0.46%) vs 7 (0.41%). Direction: the hazard ratio 0.95 is surveillance relative to endoscopy at need (fewer deaths with surveillance, 333 vs 356, and a ratio below 1), which is the opposite of the experimental-over-control order used for arm roles.
Results reported for BOSS
EndpointAnalysisEndoscopy at need2-yearly surveillance endoscopyEffect
OSIntention-to-treat populationprimarymedian follow-up 12.8 yearsOld 2025——HR 0.95 (95% CI 0.82–1.10)P=0.503333 deaths among 1733 patients (surveillance) vs 356 among 1719 (at need). The abstract states no evidence of a difference. Cancer-specific survival: 108 vs 106 deaths from any cancer (HR 1.01, 95% CI 0.77 to 1.33; P=.926). Time to diagnosis of EAC: 40 vs 31 patients diagnosed (HR 1.32, 95% CI 0.82 to 2.11; P=.254). Serious adverse events related to interventions: 8 (0.46%) vs 7 (0.41%). Direction: the hazard ratio 0.95 is surveillance relative to endoscopy at need (fewer deaths with surveillance, 333 vs 356, and a ratio below 1), which is the opposite of the experimental-over-control order used for arm roles.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.950.82–1.1
Primary publication: Old O, Jankowski J, Attwood S, Stokes C, Kendall C, Rasdell C, et al. Barrett's Oesophagus Surveillance Versus Endoscopy at Need Study (BOSS): A Randomized Controlled Trial. Gastroenterology. 2025;169(6):1233-1243.e8. PubMedDOI

Appears in

Sources

  1. Old O, Jankowski J, Attwood S, Stokes C, Kendall C, Rasdell C, et al. Barrett's Oesophagus Surveillance Versus Endoscopy at Need Study (BOSS): A Randomized Controlled Trial. Gastroenterology. 2025;169(6):1233-1243.e8.

    PubMedDOI