| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN76694943 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | CRCGICEA |
| Public title | 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 |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Colon, rectum |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN76694943 |
| Date last extracted from ISRCTN register | 17/04/2008 |
