July 16 2020
NRG Oncology National Cancer Institute (NCI) Community Oncology Research Program (NCORP) Associate Chair, Lisa Kachnic, MD, and FORTE Study Chair and Principal Investigator, Robert Schoen, MD, MPH, initiated the FORTE Workshop. This workshop centered around the new colorectal cancer prevention trial studying five versus ten year colonoscopies for patients with 1-2 non-advanced adenomatous polyps (NRG-CC005: the “FORTE” trial). The FORTE Workshop was broken down into three different parts, each tackling a different portion of the study’s conduct or best practices for trial recruitment. Each session was followed by a question and answer break out session with the audience and polls were generated during the session to gage the audience’s opinion on various FORTE-related matters.
FORTE is expected to accrue approximately 15,000 patients to the trial to determine the ideal timing to take a colonoscopy for surveillance of colorectal cancer. Previous research has indicated the range should be between 5 or 10 years. The primary endpoint for the FORTE trial is to find the rate of colorectal cancer incidence.
The first part of this session regarded trial design. Dr. Schoen presented on why FORTE was created based on background research and other members of the team delved into the protocol further. Jeffrey Dueker, MD, the FORTE Protocol Co-Chair, provided a trial overview and reviewed the eligibility criteria for accrual. Hanna Bandos, PhD, the FORTE Study Statistician, discussed the statistical overview and design of the trial.
In the second part of the session, study leadership discussed their sites’ processes in place for initialization and participant accrual for the FORTE trial. These sites included the University of Pittsburgh, Kaiser Permanente, and North Shore University Health System.
The final part of this trial surrounded resources for sites resources such as access to protocol support materials, social media options, protocol forms, VisionTree, and information about funding.