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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2001
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. CONDITION: Colon, rectum ; Cancer ; Colon, rectum PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration 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
Epistemonikos ID: e5fd1bd22a548d85985e80fdc45258d084509c82
First added on: Aug 21, 2024