December 09 2021
In the 1990s, surveillance colonoscopy for adenomas was performed yearly. Based on trial and observational data, the multi-society GI task force gradually lengthened the intervals to 5-10 years in 2012 and to 7-10 years in March 2020. Recent retrospective studies illustrate no long-term difference in cancer incidence when comparing patients with non-advanced adenomas to those with no adenoma. However, in those studies, individuals with non-advanced adenomas underwent far more colonoscopies, more adenoma removal, and more advanced adenoma removal compared to those with no adenoma. Thus, increased surveillance colonoscopy use among those with non-advanced adenomas may have been the reason for the observed, equivalent cancer incidence. Hence, existing data are inadequate to properly recommend extending surveillance intervals. The ONLY means of determining the necessity and benefit of a surveillance colonoscopy at year 5 is via a randomized trial – thus, FORTE was created.
There are 14 million colonoscopy exams per year in the U.S. The Forte trial will randomize 9,500 people, a small fraction. In clinical practice, many physicians believe the 5-year surveillance exam is beneficial and may be concerned that a 10-year interval is too long. Others may be concerned about a significant practice disruption from patient’s foregoing surveillance at 5 years. Guidelines have approved up to a ten-year surveillance interval since 2012. Within a practice, half of the subjects will be getting 5- and 10-year exams. Within a practice, a relatively small proportion will agree to participate, and participants in clinical trials are followed closely and tend to have better compliance with follow-up. Hence, the disruption to a practice by participating in the FORTE trial should be relatively minor. The trend in policy is to delay surveillance. If a colonoscopy practice believes the 5-year surveillance exam is beneficial, the only means of preserving the 5-year interval is to conduct the FORTE trial and establish the benefit of the 5-year exam.
NRG-CC005 is a prospective, randomized, non-blinded, Phase III, non-inferiority clinical trial conducted by NRG Oncology. With your help, FORTE will enroll 9500 participants with 1-2 non-advanced adenomas will be randomized to the recommendation for 10-year surveillance colonoscopy vs. 5- and 10-year surveillance. Randomization will be 1:1. The primary aim of the study is a comparison of the incidence of colorectal cancer between the two arms. FORTE is open to all NRG, NCTN members, NCORP, LAPS, main members, and affiliates.
Your site can be a part of this practice changing study by engaging your GI doctors and endoscopists at your site to refer patients to this state-of-the-art trial. The trial and all related documents are posted on the CTSU under NRG-CC005. If you have questions about NRG-CC005/FORTE, please contact the NRG Clinical Coordinating Department (CCD) at FORTE@nrgoncology.org or (800) 477-7227.