COLOFOL

Trial name or title	A pragmatic study to assess the frequency of surveillance tests after curative resection in patients with stage II and III colorectal cancer ‐ a randomised multicentre trial
Methods	RCT
Participants	Radical surgery (R0 resection) for colorectal adenocarcinoma ‐ with or without adjuvant treatment Age < 75 years "Clean colon" verified by perioperative barium enema or colonoscopy in the last 3 months post surgery Stage II to III (T2, N1‐2, M0, T3‐4, any N, M0)(Edge 2010)
Interventions	Low‐frequency follow‐up group: CEA 1 month postoperatively then CEA; CT or MRI of the liver, or both; and X‐ray/CT of the lungs 12 and 36 months after surgery High‐frequency follow‐up group: CEA 1 month postoperatively then CEA; CT or MRI of the liver or PET scans, or both; as well as X‐ray or CT of the lungs at 6, 12, 18, 24, and 36 months
Outcomes	Primary outcomes will be total mortality and cancer‐specific mortality at 5 years. Secondary outcome will be recurrence‐free survival.
Starting date	22 September 2005
Contact information	Peer Wille‐Jørgensen, MD, Dr Med Sci Department of Surgical Gastroenterology, KH:S ‐ Bispebjerg Hospital DK‐2400 Copenhagen Nordvest Denmark pwj01@bbh.hosp.dk
Notes	Study ID: NCT00225641 This study is active, but not recruiting.