October 06 2021
Philadelphia, PA – 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.
For more information about FORTE, please visit our website.
About NRG Oncology and NRG NCORP
NRG Oncology seeks to improve the lives of those at risk for or impacted by cancer. NRG Oncology conducts clinical research through its multi-national member network with a goal to conduct impactful research within its areas of expertise, including gender-specific cancers such as gynecologic, breast, and prostate cancers as well as localized or locally advanced cancers of all types. The NRG NCORP focuses on cancer prevention and control, cancer care delivery, health disparities and patient reported outcomes.
NRG Oncology is primarily funded by grants from the National Cancer Institute, and its results are regularly published in peer-reviewed journals and presented at professional society meetings, many results having a direct and meaningful impact through improving the recommended care for those at risk or being treated for cancer.
NRG Oncology Foundation, Inc., was founded in 2012 in the Commonwealth of Pennsylvania as a joint venture of the NSABP Foundation, RTOG Foundation, and GOG Foundation. As one of five research networks funded by the NCI National Clinical Trials Network and seven research bases funded by the NCI Community Oncology Program, their network includes over 1,800 sites across the United States, Canada and across the world. For more information visit www.nrgoncology.org.