Summary
NRG-GI008, also known as the “CIRCULATE-NORTH AMERICA” trial, is a clinical study for people with stage III and high-risk stage II colon cancer. The study will be seeking to determine whether chemotherapy is needed for all or only some patients in this population, and, if chemotherapy is needed, what kind of chemotherapy to recommend to patients based on the presence or absence of circulating tumor DNA (ctDNA) following surgery for colon cancer. The study aims to both spare patients who may not need chemotherapy from its side effects and, for patients who do need chemotherapy, to better determine the most effective form of chemotherapy for them.
Description
Currently, there are no biomarkers validated prospectively in randomized studies for resected colon cancer to determine need for adjuvant chemotherapy. However, circulating tumor DNA (ctDNA) shed into the bloodstream represents a highly specific and sensitive approach (especially with serial monitoring) for identifying microscopic or residual tumor cells in colon cancer patients and may outperform traditional clinical and pathological features in prognosticating risk for recurrence. Colon cancer patients who do not have detectable ctDNA (ctDNA-) are at a much lower risk of recurrence and may not need adjuvant chemotherapy. Furthermore, for colon cancer pts with detectable ctDNA (ctDNA+) who are at a very high risk of recurrence, the optimal adjuvant chemotherapy regimen has not been established. We hypothesize that for patients whose colon cancer has been resected, ctDNA status may be used to risk stratify for making decisions about adjuvant chemotherapy.
Principal Investigator
Study Coordinator
Research Contact
Lisa Luikart email lisa.luikart@vandaliahealth.org
304-388-9944