Coming Attractions or Recent Additions in NRG Colorectal Cancer Research: NRG-GI005

March 08 2022

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NRG-GI005, also known as the “COBRA” trial, is a phase II/III trial is examining circulating tumor DNA (ctDNA) as a predictive biomarker in adjuvant chemotherapy for patients with stage IIA colon cancer. This trial is currently accruing patients with resected stable stage IIA colon cancer who are considered suitable for active surveillance. Eligible patients that are enrolled in the trial will be randomly assigned to be under active surveillance and have samples taken for analysis of ctDNA status (Treatment Arm 1), or patients will be randomly assigned to receive assay-directed therapy, with samples taken for analysis of ctDNA status (Treatment Arm 2). Patients on Treatment Arm 2 who DO NOT have ctDNA detected will continue to be under active surveillance whereas patients who DO have ctDNA detected will receive additional mFOLFOX6 or CAPOX chemotherapy.

The goal of the trial of phase II of the trial is to compare the rate of ctDNA clearance in patients with detected ctDNA between treatment arms. The primary aim of the phase III portion of this trial is to compare recurrence-free survival in patients with detected ctDNA between treatment arms.

"NRG-GI005 is the first-in-kind prospective clinical trial supported by the NCI for any cancer type to evaluate ctDNA as a biomarker to assess benefit of chemotherapy after surgery.  While observational data thus far has shown promise for these technologies, medical oncologists and surgical oncologists are working together to demonstrate the utility of ctDNA in treatment decisions for patients with stage II colon cancer,” remarked Van Morris, MD, of the University of Texas MD Anderson Cancer Center and the Principal Investigator of the COBRA trial.



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