FORTE accrues first 1000 participants for highly anticipated colorectal cancer prevention trial

NRG OncologyNov 9 2023

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.