The CEA Second-Look Trial: a randomised controlled trial of carcinoembryonic antigen prompted reoperation for recurrent colorectal cancer.
OBJECTIVE
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?


METHODS
A randomised controlled trial recruiting patients from 1982 to 1993 was recovered under the Restoring Invisible and Abandoned Trials (RIAT) initiative.


METHODS
58 hospitals in the UK.


METHODS
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.


METHODS
'Second-look' surgery with intention to remove any recurrence discovered.


METHODS
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.


BACKGROUND
ISRCTN76694943.
Clinical Operational Research Unit, University College London, London, UK.
Tom
T
Treasure
Sussex Health Outcomes Research & Education in Cancer (SHORE-C), Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, UK.
Kathryn
K
Monson
Department of Cardiothoracic Surgery, NHLI, Imperial College London, London, UK.
Francesca
F
Fiorentino
Department of Surgery, University College London, London, UK.
Christopher
C
Russell
D000230:Adenocarcinoma / Q000097:blood* / Q000601:surgery*; D000328:Adult; D000368:Aged; D002272:Carcinoembryonic Antigen / Q000097:blood*; D015179:Colorectal Neoplasms / Q000097:blood* / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000097:blood* / Q000601:surgery*; D012086:Reoperation; D016037:Single-Blind Method
D002272:Carcinoembryonic Antigen
CHEMICAL PATHOLOGY