A randomized trial of intensive versus minimal surveillance of patients with resected Dukes B2-C colorectal carcinoma

Ann Oncol. 2016 Feb;27(2):274-80. doi: 10.1093/annonc/mdv541. Epub 2015 Nov 16.


Background: Colorectal cancer is the third most common and the third most lethal cancer in both men and women in developed countries. About 75% of cases are first diagnosed when the disease is classified as localized or regional, undergo potentially curative treatment and enter a post-treatment surveillance program. Although such programs drain significant resources from health systems, empirical evidence of their efficacy is scanty.

Patients and methods: Dukes B2-C colorectal cancer patients who had no evidence of disease at the end of their front-line treatment (surgery and adjuvant radiochemotherapy, if indicated) were eligible for the trial and randomized to two different surveillance programs. These programs differed greatly in the frequency of diagnostic imaging. They had similar schedules of physical examinations and carcinoembryonic antigen (CEA) assessments. Patients received baseline and yearly health-related quality-of-life (HR-QoL) questionnaires. Primary outcomes were overall survival (OS) and QoL.

Results: From 1998 to 2006, 1228 assessable patients were randomized, 933 with colon cancer and 295 with rectal cancer. More than 90% of patients had the expected number of diagnostic procedures. Median follow-up duration was 62 months [interquartile range (IQR) 51-86] in the minimal surveillance group and 62 months (IQR 50-85) in the intensive group. At primary analysis, 250 patients had recurred and 218 had died. Intensive surveillance anticipated recurrence, as shown by a significant difference in mean disease-free survival of 5.9 months. Comparison of OS curves of the whole intention-to-treat population showed no statistically significant differences. HR-QoL of life scores did not differ between regimens.

Conclusion: Our findings support the conclusions of other randomized clinical trials, which show that early diagnosis of cancer recurrence is not associated with OS benefit.

Clinicaltrialsgov: NCT02409472.

Keywords: colorectal carcinoma; randomized clinical trial.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Carcinoembryonic Antigen / blood
  • Chemoradiotherapy, Adjuvant
  • Colonic Neoplasms / diagnosis*
  • Colonic Neoplasms / mortality
  • Colonic Neoplasms / therapy
  • Colonoscopy / methods*
  • Diagnostic Imaging
  • Disease-Free Survival
  • Early Detection of Cancer / methods*
  • Female
  • Humans
  • Male
  • Neoplasm Recurrence, Local / mortality
  • Neoplasm Recurrence, Local / prevention & control*
  • Patient Outcome Assessment
  • Quality of Life
  • Rectal Neoplasms / diagnosis*
  • Rectal Neoplasms / mortality
  • Rectal Neoplasms / therapy
  • Surveys and Questionnaires
  • Treatment Outcome


  • Carcinoembryonic Antigen

Associated data

  • ClinicalTrials.gov/NCT02409472