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BMJ Open. 2014 May 13;4(5):e004385. doi: 10.1136/bmjopen-2013-004385.

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

Author information

1
Clinical Operational Research Unit, University College London, London, UK.
2
Sussex Health Outcomes Research & Education in Cancer (SHORE-C), Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, UK.
3
Department of Cardiothoracic Surgery, NHLI, Imperial College London, London, UK.
4
Department of Surgery, University College London, London, UK.

Abstract

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?

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.

KEYWORDS:

CHEMICAL PATHOLOGY

PMID:
24823671
PMCID:
PMC4025449
DOI:
10.1136/bmjopen-2013-004385
[Indexed for MEDLINE]
Free PMC Article

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