FORTE, a colorectal cancer prevention clinical trial, accrues its first 1000 participants

FORTE (NRG-CC005) is a highly anticipated colorectal cancer prevention trial led by NRG Oncology examining surveillance colonoscopy intervals in participants who have non-advanced polyps. Expected to enroll 9,500 participants (about 4,750 people in each study group), we are excited to announce that FORTE accrued its 1000^th participant on October 30, 2023. With over 30 sites actively accruing patients, we continue to expand our network of clinical research sites screening patients for FORTE.

FORTE (Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps) is a randomized trial for patients who had 1 or 2 small benign polyps (adenomas) removed at colonoscopy. Participants are assigned to have their next surveillance colonoscopy exam, at 5 years and at 10 years or at 10 years. The primary objective is to determine the benefit of the colonoscopy exam at 5 years.

Why Join the FORTE Study?

According to Robert E. Schoen, MD, MPH, Professor of Medicine & Epidemiology at the University of Pittsburgh and Principal Investigator of 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.” Around 30% of people screened for colorectal cancer with colonoscopy are found to have these small polyps, so the results of FORTE will have a big impact on health care and cancer prevention. Furthermore, if FORTE shows that fewer colonoscopies are needed for people with these small polyps, doctors can further emphasize and direct colonoscopy exams to people who have not been screened, improving public health. The American College of Gastroenterology (ACG), the American Society for Gastrointestinal Endoscopy (ASGE), and the American Gastroenterological Association (AGA) have formally expressed their support for the conduct of the trial and encourage participation by endoscopists and eligible patients. 

For more information about FORTE, please visit our website to find a participating location.

About NRG Oncology and NRG NCORP

The National Cancer Institute (NCI) , part of the National Institutes of Health,  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 funded and conducted through NCORP, in conjunction with members of the National Clinical Trials Network (NCTN). The trial is led by NRG Oncology with the participation of other network organizations: Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, and SWOG.

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.