November 11 2021
On October 6, 2021 NRG Oncology activated the highly anticipated colorectal cancer prevention trial, FORTE/NRG-CC005. FORTE (Five- or Ten-Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps) is a large, randomized trial of surveillance colonoscopy for participants with a first-time diagnosis of 1 or 2 small adenomas. Participants will be assigned to having their next colonoscopy exam at 5 years and again at 10 years or their next colonoscopy exam at 10 years. The study is planning to enroll 9,500 participants (about 4,750 people in each study group).
According to Robert E. Schoen, MD, MPH, Chief, Division of Gastroenterology, Hepatology and Nutrition at the University of Pittsburgh and Principal Investigator for FORTE, “The optimal timing for a repeat colonoscopy for people with 1 or 2 small benign adenomas removed during colonoscopy is uncertain. This study will measure and compare colorectal cancer incidence rates and adverse effects from colonoscopy in the two study groups. If the cancer rates are similar to each other, then a 5-year follow-up surveillance colonoscopy exam may not be needed.”
Philip E. Castle, PhD, MPH, Director of the Division of Cancer Prevention at the National Cancer Institute (NCI), part of the National Institutes of Health, explains, “In addition to FORTE answering the critical question about best practices for management of people found to have 1-2 small polyps on colonoscopy screening, participants are being ask to provide blood, stool, and other tissues for additional studies to help us better understand how colorectal cancer develops from a polyp.”
Now that the trial is activated, sites must begin to identify research study staff for the trial and establish collaborations and referral patterns with gastroenterologists and endoscopists within their institution and community. They need to start to implement mechanisms and processes to facilitate recruitment and enrollment. In addition to enrolling participants who are found to have polyps on current colonoscopy exams, the trial permits a “look back”, with enrollment of individuals with a history of 1 or 2 small adenomas within the previous 4 years.
Key FORTE entry criteria for entry include:
- Participants ³ 50 and < 70 years of age at the time of randomization
- Colonoscopy with 1 or 2 <1cm adenomatous polyps
- Pathology report – tubular or serrated adenomas
- No advanced adenomas
- No prior adenomas
Also please pay close attention to the NRG Oncology weekly broadcasts as items for sites to use when working with the FORTE trial will begin to be rolled out in the broadcasts over the next several weeks.
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 FORTE@nrgoncology.org or 1-800-477-7227.