June 16 2021
NRG Oncology NCORP (NCI Community Oncology Research Program) is thrilled to announce that the NRG-CC005/FORTE study has been approved by the NCI Central Institutional Review Board (CIRB) and is pending final approval by the Division of Cancer Prevention (DCP) at the National Cancer Institute. The FORTE study leadership team is anticipating an early summer activation.
As the practice of colonoscopy expands to include the vast majority of adults and the detection of an adenoma at colonoscopy increases, the inconvenience, medical risk, and resources associated with and devoted to surveillance, or colonoscopy after the finding of polyps, will increase. 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-year vs. 10-year surveillance for participants with non-advanced adenoma is needed to guide clinical practice. Your support and involvement with the trial is critical to its success.
NRG-CC005 is a prospective, randomized, non-blinded, Phase III, 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. Randomization will be 1:1. The primary aim of the study is a comparison of the incidence of colorectal cancer between the two arms.
This trial is part of the National Clinical Trials Network (NCTN) program, which is sponsored by the National Cancer Institute (NCI).The trial will be led by NRG Oncology with the participation of the network of NCTN organizations: Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, NRG Oncology, and SWOG. FORTE is open to all NRG, NCTN members, NCORP, LAPS, main members and affiliates.
The FORTE study team encourages sites to begin pre-launch preparation to take part in this colorectal cancer prevention study. Begin to identify your research study staff, establish potential collaborations/referral patterns within your institution and your community, and begin to develop and plan for implementation mechanisms to facilitate recruitment.
If you have questions about the NRG-CC005 / FORTE study, please contact the Clinical Coordinating Department (CCD) at ccdpgh@nrgoncology.org or 1-800-477-7227.
Protocol Chair: Robert E. Schoen, MD, MPH
Assistant Protocol Chair: Jeffrey M. Dueker, MD, MPH
Chief Scientific Officer: Douglas Corley, MD, PHD