eP826 - NRG-GI008: Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE - NORTH AMERICA)

Monday, June 3, 2024

1:57 PM – 2:02 PM ET, USA

Location: Room 318-320

ePoster Presenter(s)

Yesenia Rojas-Khalil, MD (she/her/hers)

Assistant Professor
Baylor College of Medicine
Houston, TX, United States

All relevant financial disclosures have been managed and will be listed below.
This individual has no financial relationships with ineligible companies.

Author(s)

GY

Guan Yu, PhD

Associate Professor
Department of Biostatistics, University of Pittsburgh School of Public Health; NRG Oncology Statistical and Data Management Center
Pittsburgh, Pennsylvania, United States

Disclosure information not submitted.
SK

Scott Kopetz, MD, PhD

Associate Vice President, Translational Integration
University of Texas MD Anderson Cancer Center
Houston, Texas, United States

Disclosure information not submitted.
SP

Shannon L. Puhalla, MD

Medical Oncologist
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States

Disclosure information not submitted.
PL

Peter C. Lucas, MD, PhD

Vice Chair of Research for Laboratory Medicine and Pathology
Mayo Clinic
Rochester, Minnesota, United States

Disclosure information not submitted.
IS

Ibrahim H. Sahin, MD

Associate Professor
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States

Disclosure information not submitted.
DD

Dustin A. Deming, MD

Associate Professor
Univesity of Wisconsin
Madison, Wisconsin, United States

Disclosure information not submitted.
PP

Philip A. Philip, MD, PhD, FRCP

Medical Oncologist
Henry Ford Cancer Institute, Wayne University School of Medicine
Detroit, Michigan, United States

Disclosure information not submitted.
TH

Theodore S. Hong, MD

Radiation Oncologist
Massachusetts General Hospital Cancer Center; and Harvard Medical School
Boston, Massachusetts, United States

Disclosure information not submitted.
JL

Jonathan M. Loree, MD, FRCPC

Medical Oncologist
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada

Disclosure information not submitted.
NW

Norman Wolmark, MD

Chair
NSABP Foundation, Inc.; UPMC HIllman Cancer Center; and University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States

Disclosure information not submitted.
GY

Greg Yothers, PhD

Research Professor of Biostatistics
Department of Biostatistics, University of Pittsburgh School of Public Health; NRG Oncology Statistical and Data Management Center
Pittsburgh, Pennsylvania, United States

Disclosure information not submitted.
TG

Thomas J. George, MD

Deputy Director
University of Florida Health Cancer Center
Gainesville, Florida, United States

Disclosure information not submitted.
CL

Christopher H. Lieu, MD

Co-Director of GI Medical Oncology
University of Colorado Cancer Center
Aurora, Colorado, United States

Disclosure information not submitted.

Senior Author(s)

AD

Arvind Dasari, MD, MS

Associate Professor
University of Texas MD Anderson Cancer Center
Houston, Texas, United States

Disclosure information not submitted.

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Purpose/Background: Currently, there are no biomarkers validated prospectively in randomized studies for resected colon cancer (CC) to determine need for adjuvant chemotherapy (AC). However, circulating tumor DNA (ctDNA) represents a highly specific and sensitive approach (especially with serial monitoring) for identifying minimal/molecular residual disease (MRD) post-surgery in CC patients (pts), and may outperform traditional clinical and pathological features in prognosticating risk for recurrence. CC pts who do not have detectable ctDNA (ctDNA-) are at a much lower risk of recurrence and may be spared the toxicities associated with AC. Furthermore, for CC pts with detectable ctDNA (ctDNA+) who are at a very high risk of recurrence, the optimal AC regimen has not been established. We hypothesize that for pts whose CC has been resected, ctDNA status may be used to risk-stratify for making decisions about AC.Methods/Interventions: In this prospective phase II/III trial, up to 1,912 pts with resected stage IIB, IIC, and III CC will be enrolled. Based on the post-operative ctDNA status using personalized and tumor-informed assay (Signatera [TM], bespoke assay), those who are ctDNA- (Cohort A) will be randomized to immediate AC with fluoropyrimidine (FP) + oxaliplatin (Ox) for 3-6 mos per established guidelines v. serial ctDNA monitoring. Patients who are ctDNA+ post-operatively, or with serial monitoring (Cohort B), will be randomized to FP+Ox v. more intensive AC with addition of irinotecan (I) for 6 mos. One cycle of chemotherapy is allowed while awaiting ctDNA testing results for cohort assignment. Primary endpoints for Cohort A are time to ctDNA+ status (phase II) and disease-free survival (DFS) (phase III) in the immediate v. delayed AC arms. Primary endpoint for Cohort B is DFS in the FP+Ox v. FP+Ox+I arms for both phase II and phase III portions of the trial. Secondary endpoints include prevalence of detectable ctDNA post-operatively, time-to-event outcomes (overall survival and time to recurrence) by ctDNA status, and the assessment of compliance to adjuvant therapy. Biospecimens including archival tumor tissue, as well as post-operative plus serial matched/normal blood samples, will be collected for exploratory correlative research.

NCT05174169
Support: U10CA-180868, -180822; UG1CA189867; Natera, Inc.Results/Outcomes: Active enrollment across the NCTN began in June 2022, with CCTG sites joining in August 2023.
Current accrual (as of 02-12-2024) is 243/1,912.Conclusion/

Discussion: N/A