FORTE Colorectal Cancer Prevention Trial
What is the FORTE study?
The FORTE (Five- or Ten-Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps) study will help to determine if certain people can wait for a follow-up colonoscopy after a routine screening colonoscopy. It is a randomized clinical trial for people who have one or two small, noncancerous polyps (adenomas) removed during a routine screening colonoscopy. Such people usually get repeat colonoscopies 5 years and 10 years later (the current standard of care for people who have had one or two benign polyps removed). FORTE will help determine if these people can wait 10 years before a follow-up test.
A total of 9,500 people who have had one or two benign (noncancerous) polyps removed during a routine screening colonoscopy will be assigned by chance to one of two study groups. In one group, participants will have repeat colonoscopies at both 5 and 10 years. In the other group, participants will have their next colonoscopy exam at 10 years.
Who is eligible to participate?
People aged 50 to 69 who have had a complete screening colonoscopy within the past 4 years and were found to have one or two small, noncancerous polyps may qualify to join the study. The polyps must have been completely removed during the colonoscopy. People with a previous history of colon or rectal polyps, colorectal cancer, or who have a family history of colorectal cancer are not eligible to participate.
What are the goals of the FORTE study?
People participating in the trial will be assigned by chance (randomized) to one of two study groups. People in one group will have follow-up colonoscopies at 5 years and 10 years. Those in the other group will have their next colonoscopy at 10 years, in keeping with current guidelines for those with negative results. By comparing colorectal cancer rates in the two groups, researchers will learn if waiting 10 years for a follow-up colonoscopy is as good at preventing colorectal cancer as follow-up colonoscopy exams at both 5 years and 10 years.
Why is the FORTE study important?
Several studies suggest that the risk of colorectal cancer developing after a colonoscopy in which one or two small polyps were removed is similar to that of people who had a colonoscopy with no polyps found. People without polyps are recommended to return in 10 years. The recommended follow up for people with one or two small adenomas is 5 to 10 years.
If people in the 10-year colonoscopy group have a colorectal cancer rate that is not worse than those in the group with colonoscopy at 5 and 10 years, then in the future, a 5-year follow-up colonoscopy exam may not be needed. This would eliminate the need for an additional colonoscopy, which is costly, time consuming, and may have medical risk.
Who is sponsoring the FORTE study?
NCI’s Division of Cancer Prevention is sponsoring the FORTE study, which is being conducted through the NCI Community Oncology Research Program. The study is led by NRG Oncology Group, part of NCI’s National Clinical Trials Network.
How can I learn more about the FORTE study?
For more information about the FORTE study, see the protocol abstract or visit NRG Oncology’s About This Study page.