A multicentre trial to evaluate the use of serial carcinoembryonic antigen (CEA) assay as the prime indicator for second-look surgery in recurrent colorectal cancer

ISRCTN	ISRCTN76694943
DOI	https://doi.org/10.1186/ISRCTN76694943
Secondary identifying numbers	CRCGICEA

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1998
Completion date	31/12/2000

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1998
Date of final enrolment	31/12/2000

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	13/05/2014		Yes	No