Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
16/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CRCGICEA

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colon, rectum

Intervention

All patients receive primary potentially curative surgery. Patients are randomised if a significant rise in serum CEA is detected to either:

1. Conventional Arm: Observation only. The patient is monitored until there is clinical evidence of recurrent disease. The clinician is not informed of the rise in serum CEA.

2. Aggressive Arm : The surgeon is informed of the rise in serum CEA, and in the absence of objective evidence either of a non-malignant cause for the CEA rise or of incurable distant metastases, second-look laparotomy is carried out to locate and remove treatable recurrence.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1998

Overall trial end date

31/12/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 75 or under
2. Potentially curative resection performed for colorectal adenocarcinoma
3. No evidence of distant incurable spread (clinically or at surgery)
4. No evidence of hepatic, renal, pancreatic or infective disease
5. Willing to attend regular CEA monitoring in addition to clinical follow-up for 5 years

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1998

Recruitment end date

31/12/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24823671

Publication citations

  1. Results

    Treasure T, Monson K, Fiorentino F, Russell C, The CEA Second-Look Trial: a randomised controlled trial of carcinoembryonic antigen prompted reoperation for recurrent colorectal cancer., BMJ Open, 2014, 4, 5, e004385, doi: 10.1136/bmjopen-2013-004385.

Additional files

Editorial Notes