Today, 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 benign polyps, called adenomas. Participants in the study will be assigned to having their next colonoscopy exam at 5 years and at 10 years or their next colonoscopy exam at 10 years. The study is expected to enroll 9,500 participants (about 4,750 people in each study group).
The primary objective of the study is to determine whether people who had 1 or 2 small benign polyps removed during colonoscopy should have their repeat colonoscopy exam at 10 years or should they have their repeat exams at both 5 years and at 10 years?
According to Robert E. Schoen, MD, MPH, Chief, Division of Gastroenterology, Hepatology and Nutrition at the University of Pittsburgh Department of Medicine and Principal Investigator for FORTE, "The best timing for a repeat colonoscopy for people with 1 or 2 small benign polyps removed during colonoscopy is not known. This study will measure and compare the colorectal cancer incidence rates 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."
Participants in FORTE are also being asked to submit blood, stool, and tissues from polyps as part of the research. 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."
The NCI Division of Cancer Prevention leads the NCI Community Oncology Research Program (NCORP). NCORP is a national network of investigators and cancer care providers that conduct multisite cancer clinical trials in prevention, screening, symptom management, and cancer care delivery. FORTE is being conducted through NCORP, in conjunction with members of the National Clinical Trials Network (NCTN). The trial will be led by NRG Oncology with the participation of other network organizations: Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, and SWOG.