Sponsor: NRG
Sponsor Study ID: NRG-GI008
Study Title: Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-North America)
CTO #: 104069
NCT Number: NCT05174169
Phase: II/III
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Colon
Study Objectives: To compare time to ctDNA (+ve) status in ctDNA (-ve) cohort following resection of stage III colon cancer treated with immediate vs delayed (based on serial ctDNA surveillance) chemotherapy. Time to positive event is defined as time from randomization to the first ctDNA postive result for the immediate arm (arm 1) and to the 2nd ctDNA positive result for the delated arm (arm 2) to allow for the potential effect of delayed adjuvant chemotherapy. Patients recurred without a positive ctDNA result will be considered to have ctDNA positive status at the time of recurrence for both study arms.