Trials in Progress Update: CIRCULATE-NORTH AMERICA (NRG-GI008)

March 12 2024

CIRCULATE-NORTH AMERICA (NRG-GI008): Colon Adjuvant Chemotherapy based on Evaluation of Residual Disease

The CIRCULATE-NORTH AMERICA (NRG-GI008) trial is examining colon adjuvant chemotherapy based on evaluation of residual disease and is currently accruing patients with high-risk stage II or any stage III 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 (standard of care) or they will be monitored via serial ctDNA testing and will not receive chemotherapy unless they convert to ctDNA+. 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 (standard of care) or to receive mFOLFIRINOX (intensification of chemotherapy).

“NRG-GI008 will help determine how we might use circulating tumor DNA (ctDNA) to guide the best therapy for patients with 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.

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