September 14 2021
NRG Oncology NCORP (NCI Community Oncology Research Program) is eagerly anticipating the imminent activation of NRG-CC005 / FORTE: (Five- or Ten-Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps). The study has been approved by the Division of Cancer Prevention (DCP) at the National Cancer Institute and by the NCI Central Institutional Review Board (CIRB). The FORTE study team is conducting final preparations before activating the trial.
NRG-CC005/FORTE is a phase III prospective, randomized non-inferiority clinical trial conducted by NRG Oncology. Participants with 1-2 non-advanced adenomas will be randomized to the recommendation for 10-year surveillance colonoscopy vs. 5- and 10-year surveillance. The primary aim of the study is a comparison of the incidence of colorectal cancer between the two arms.
Research to determine the benefit and yield of surveillance colonoscopy in patients with non-advanced adenomas is a high priority because of the high prevalence of adenomas and the uncertainty about their medical risk. A randomized clinical trial to evaluate the difference in yield between 5 and 10 vs. 10-year surveillance for participants with non-advanced adenoma is needed to guide clinical practice.
The NRG FORTE study team encourages sites to begin pre-launch activities such as: identify research study staff for the trial; establish potential collaborations/referral patterns with gastroenterologists and endoscopists within your institution and community; develop implementation mechanisms and processes to facilitate recruitment and enrollment; approach patient advocacy groups that might be interested in partnering with your FORTE study team.
Do you have access to colonoscopy and pathology reports from colonoscopy exams in the previous
4 years? These records could be reviewed to retrospectively identify participants for the trial. The trial can help with “reading” these reports with natural language processing (NLP) software. NLP could be used to identify potential study participants.
Key FORTE entry criteria for retrospective review include patients diagnosed in previous 4 years with:
- Participants ³ 50 and < 70 years of age at the time of randomization
- Colonoscopy with 1 or 2 <1cm polyps
- Pathology report – tubular or serrated adenomas
- No advanced adenomas
- No prior adenomas
Protocol Chair: Robert E. Schoen, MD, MPH
Assistant Protocol Chair: Jeffrey M. Dueker, MD, MPH
Chief Scientific Officer: Douglas Corley, MD, PHD
If you have questions about the NRG-CC005 / FORTE study, please contact the NRG Clinical Coordinating Department (CCD) at firstname.lastname@example.org or 1-800-477-7227.