BMJ_Open-2014-Treasure-.pdf (3.24 MB)
The CEA Second-Look Trial: a randomised controlled trial of carcinoembryonic antigen prompted reoperation for recurrent colorectal cancer
journal contribution
posted on 2023-06-08, 17:38 authored by Tom Treasure, Kathryn Monson, Francesca Fiorentino, Christopher RussellObjective In patients who have undergone a potentially curative resection of colorectal cancer, does a ‘second-look’ operation to resect recurrence, prompted by monthly monitoring of carcinoembryonic antigen, confer a survival benefit?Design A randomised controlled trial recruiting patients from 1982 to 1993 was recovered under the Restoring Invisible and Abandoned Trials (RIAT) initiative.Setting 58 hospitals in the UK.Participants From 1982 to 1993, 1447 patients were enrolled. Of these 216 met the criteria for carcinoembryonic antigen (CEA) elevation and were randomised to ‘Aggressive’ or ‘Conventional’ arms.Interventions ‘Second-look’ surgery with intention to remove any recurrence discovered.Primary outcome measure Survival.Results By February 1993, 91/108 patients had died in the ‘Aggressive arm’ and 88/108 in the ‘Conventional’ arm (relative risk=1.16, 95% CI 0.87 to 1.37). By 2011 a further 25 randomised patients had died. Kaplan-Meier analysis showed no difference in long-term survival.Conclusions The trial was closed in 1993 following a recommendation from the Data Monitoring Committee that it was highly unlikely that any survival advantage would be demonstrated for CEA prompted second-look surgery. This conclusion was confirmed by repeat analysis of survival times after 20 years.Trial registration number ISRCTN76694943.
History
Publication status
- Published
File Version
- Published version
Journal
BMJ OpenISSN
2044-6055Publisher
British Medical AssociationExternal DOI
Issue
5Volume
4Article number
e004385Department affiliated with
- Sussex Health Outcomes Research & Education in Cancer (SHORE-C) Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2014-06-19First Open Access (FOA) Date
2014-06-19First Compliant Deposit (FCD) Date
2014-06-19Usage metrics
Categories
No categories selectedLicence
Exports
RefWorks
BibTeX
Ref. manager
Endnote
DataCite
NLM
DC