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
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
-
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.