January 12 2022
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 adenomas. Participants 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 planning to enroll 9,500 participants (about 4,750 people in each study group).
Protocol Chair: Robert E. Schoen, MD, MPH
Assistant Protocol Chair: Jeffrey M. Dueker, MD, MPH
Chief Scientific Officer: Douglas Corley, MD, PHD
THE NRG-CC005 TRIAL (FORTE) Amendment #3 is now active
As of December 2021, the NRG-CC005 Amendment 3 (NCI Version Date: November 2, 2021) is active in the US. The primary purpose of Amendment 3 is to clarify that after the consent form is signed, the baseline blood sample may be collected (either before or after randomization). This clarification is also reflected in the consent form. Neither participants or their insurance providers are responsible for costs of the storage of samples for biobanking. See the summary of changes outlines changes for Amendment 3 for the complete list of changes made to the CC005/FORTE protocol as part of Amendment 3.
Establishing your referral network
As you continue to review and work to open and operationalize the FORTE/NRG-CC005 trial, remember establishing and maintaining relationships with your referring gastroenterologists, endoscopists and site physicians within your institution and community is of great importance for your successful accrual.
The FORTE study has established a Supplemental Incentive Payment Program. Funding is limited to 60 Site Networks and subject to the approval of NRG Oncology. Details are provided in the CC005 Funding Sheet and the related Site Network Establishment Application Form, which are both posted to the CC005 page in the Members’ Area of the CTSU website.
The FORTE Team has developed initial resources to help you introduce and spread the work about FORTE to these physicians. These documents are posted on the CTSU website under NRG-CC005/ FORTE/documents/education and promotion.
GI Societies Endorsement Letter-The NRG-CC005/FORTE Trial is endorsed by the following GI Societies: American College of Gastroenterology, American Gastroenterological Association, and American Society for Gastrointestinal Endoscopy
Intro for Endoscopist- An introduction written for endoscopists in a questions and answer format.
Intro for Primary Care/MDs- An introduction for possible referring physician in a questions and answer format. The document contains a place to insert your site information.
FORTE Fast Facts- A general questions and answer document for health care professionals. The site version is for you and your colleagues who are screening and enrolling patients. The affiliate version is for announcement and education as you are introducing the trial to your affiliates and referring physicians. This version contains a place to insert your site contact information.
Questions and Comments
The NRG-CC005 Study Team welcomes your input. If you have questions about the NRG-CC005 / FORTE study, suggestions for site or patient resources or have an example or best practice of success from your site that you would like to share with colleagues, please contact the NRG Clinical Coordinating Department (CCD) at FORTE@nrgoncology.org or 1-800-477-7227.