FORTE Study Updates: September 2025

September 16 2025

NRG-CC005 Amendment #8: VisionTree Updates

NRG-CC005 Amendment 8 (NCI Version Date: April 28, 2025) was activated on June 10, 2025, in the United States. Section 11.2 and 11.3 regarding the Optional Online Completion of Participant-Reported Outcomes Questionnaires were updated to indicate the length of time PRO questionnaires are available in VisionTree:

“The CC005 Participant-Reported Outcome Questionnaires will ideally be completed within 3 months after the participant has been randomized on the study, but questionnaires completed after that time (up to a year) should be submitted. Participants may complete the questionnaires on paper or via VisionTree Optimal Care (VTOC). VisionTree forms are available for only 105 days from randomization. Any forms not completed in that time must be completed on paper (collection over the phone or via mail is permitted). If questionnaires are not completed via VTOC, the questionnaires may be completed via paper and manually entered into Rave by site staff. When absolutely necessary, the questionnaire may be administered by telephone or mail (see Appendix I). Sites are responsible for providing the paper questionnaires to participants in a timely manner if VTOC is not used.

The physical versions of paper questionnaires should not be submitted to NRG Oncology but should be retained in the participant's chart for audit purposes.”

Accrual Updates and Milestones (as of September 1, 2025)

Top accruing sites: 

Kaiser Permanente – Vallejo – 1689 accrued  

UPMC-Presbyterian Hospital – 333 accrued 

Regions Hospital – 144 accrued  

Most recent randomizations:  

Yale University – September 2, 2025  

Kaiser Permanente-Vallejo – August 29, 2025  

Kaiser Permanente-San Diego Zion – August 29, 2025  

Kaiser Permanente-Irvine – August 29, 2025  

John H Stroger Jr Hospital of Cook County – August 29, 2025  

UPMC-Presbyterian Hospital – August 29, 2025  

Providence Veterans Administration Hospital – August 29, 2025  

FORTE Top 25 Accruing Sites – September 2, 2025  

FORTE Accrual Sept 2025.png

FORTE Resource Portal  

Bookmark this website, that organizes materials found on CTSU: https://www.nrgoncology.org/Clinical-Trials/NRG-CC005/FORTE-Resource-Portal. You will use the same login information as for CTSU to access this page. Once you gain access, the “FORTE Materials for Research Professionals” section contains many materials to assist you with accruing participants. This website also has contact information for questions you may have while working on NRG-CC005.

Find both CIRB-approved and protocol-related documents on CTSU under NRG-CC005.

Do you have new research team members working on NRG-CC005?

Clinical research professionals can sign up for NRG Weekly Broadcasts to receive FORTE Fridays updates directly to your inbox: https://www.nrgoncology.org/Home/News/Weekly-Broadcasts.

Questions from Site Research Staff

If research staff have questions about a patient's eligibility or study logistics for the NRG-CC005/FORTE Study, contact the Clinical Coordinating Department (CCD) at: FORTE@nrgoncology.org or 1 (800) 477-7227.

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