Dr. Hubbard on the Design of the NRG-GI005 Trial in Colorectal Cancer

Joleen M. Hubbard, MD, associate professor, oncology, consultant, practice chair, vice chair, Division of Medical Oncology, Department of Oncology, Mayo Clinic, discusses the design of the the ongoing phase 2/3 NRG-GI005 trial (NCT04068103) in patients with stage IIA colorectal cancer (CRC) after surgery.

This study is evaluating whether circulating tumor DNA (ctDNA) can be utilized to safely inform treatment decisions in patients with resected, stage IIA CRC, Hubbard says. In the first arm of the 2-arm study, patients undergo active surveillance, whereas patients receive investigator’s choice of adjuvant chemotherapy in the second arm. ctDNA samples are collected in both arms and will be analyzed retrospectively down the line, Hubbard explains. 

Moreover, this study may inform whether ctDNA can guide which patients should receive treatment, while also comparing adjuvant chemotherapy with active surveillance. Overall, there is a lot to learn from the results of this study, which could provide answers to remaining questions, Hubbard concludes.