March 08 2022
NRG-GI008
ctDNA in Adjuvant Stage II/III
Activating in March 2022
NRG-GI008, also known as the “CIRCULATE-US” study, is a phase II/III trial expected to open to enrollment in March 2022.
This trial will be examining colon adjuvant chemotherapy based on evaluation of residual disease.
The CIRCULATE-US study will accrue patients with stage III resected colon cancer or circulating tumor DNA positive (ctDNA+) Stage II or Stage IIIC resected colon cancer. Patients will undergo central ctDNA testing and then will be assigned to either Cohort A with ctDNA negative (ctDNA-) status or to Cohort B with ctDNA positive (ctDNA+) status. Cohort A, ctDNA- patients will be stratified by colon cancer stage and intended chemotherapy treatment then will be randomly assigned to receive either mFOLFOX6/CAPOX or they will be monitored via serial ctDNA testing. Patients in Cohort B will be stratified by intended chemotherapy treatment and post-op ctDNA status then will be randomly assigned to receive either mFOLFOX/CAPOX or to receive mFOLFIRINOX.
““NRG-GI008 (CIRCULATE-US) will help determine how we might use circulating tumor DNA (ctDNA) to guide the best therapy for patients with stage III colon cancer. We know that patients who are ctDNA negative appear to have good outcomes, and patients that are ctDNA positive have high rates of cancer recurrence. NRG-GI008 will help us understand if patients who are ctDNA negative need chemotherapy, and whether intensification of treatment can help patients who are ctDNA positive. ctDNA is an incredibly exciting technology and trials like NRG-GI008 will help us utilize these tests to help our patients receive the best treatment possible for their cancer,” stated Arvind Dasari, MD, MS, of the University of Texas MD Anderson Cancer Center and Christopher Lieu, MD, of University of Colorado Anschutz Medical, the Co-Principal Investigators of the NRG-GI008 trial.
