NCT00995202

Trial name or title	Follow‐up care with or without CEA assessments in patients who have undergone surgery for stage II or stage III colorectal cancer
Methods	RCT n = 1925
Participants	Pathologically confirmed adenocarcinoma of the colon or rectum Stage II or III disease No distant metastatic disease Has undergone curative resection for no residual tumour Carcinoembryonic antigen (CEA) ≤ 1.5 x upper limit of normal after surgery WHO performance status 0 to 1 Not pregnant or nursing Fertile participants must use effective contraception No inflammatory bowel disease No other malignancy within the past 5 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix, or both No genetic syndromes
Interventions	Other: diagnostic laboratory biomarker analysis Procedure: computed tomography Procedure: diagnostic colonoscopy Procedure: standard follow‐up care Procedure: ultrasound imaging
Outcomes	Overall survival Disease‐free survival Curative resection rate in case of recurrence 5‐year overall survival rate Cost‐effectiveness study Quality of life
Starting date	Study start date: September 2009 Estimated primary completion date: April 2018
Contact information	Come Lepage, MD Centre Hospitalier Universitaire de Dijon
Notes	This study is ongoing, but not recruiting participants.