KEY TAKEAWAYS
- The CIRCULATE-US, a phase II/III trial, aims to hypothesize that ctDNA status can be used to determine the risk of recurrence after colon cancer resection.
- Patients with resected CC (stage III A, B, and stage II, IIIC ctDNA+) will be enrolled.
- The primary endpoints for Cohort A are time to ctDNA+ status (phase II) and DFS (phase III) in immediate vs. delayed AC arms. In Cohort B, DFS in FP+Ox vs FP+Ox+I arms for both phases.
Circulating tumor DNA (ctDNA) shows promise as a sensitive method to identify minimal residual disease post-surgery. Researchers aim to evaluate the ctDNA efficacy to determine the risk of recurrence after colon cancer resection and thus help guide decisions about adjuvant chemotherapy.
In this study, approximately 1,912 patients (pts) with resected stage III A, B (all pts), and stage II, IIIC (ctDNA+ only) colon cancer will be included. Based on their postoperative ctDNA status, ctDNA- pts (Cohort A) will be randomized for immediate fluoropyrimidine (FP) + oxaliplatin (Ox) adjuvant chemotherapy or ctDNA monitoring. ctDNA+ pts (Cohort B) will be randomized for FP+Ox chemotherapy or more intensive treatment with the addition of irinotecan (I) for 6 months.
In Cohort A, the primary endpoints are time to ctDNA+ status (phase II) and disease-free survival (DFS) (phase III) for immediate vs. delayed adjuvant chemotherapy arms. In Cohort B, the primary endpoint is DFS for FP+Ox vs. FP+Ox+I arms in phases II and III. Secondary endpoints include detectable ctDNA prevalence after surgery, time-to-event outcomes (overall survival and time to recurrence) based on ctDNA status, and evaluation of adjuvant therapy compliance. The study will use the SignateraTM assay for ctDNA assessment.
Source: https://meetings.asco.org/abstracts-presentations/225842
Clinical Trial: https://www.clinicaltrials.gov/study/NCT05174169
Arvind Dasari, Guan Yu, Scott Kopetz, Samuel A. Jacobs, Peter C. Lucas, Ibrahim Halil Sahin, Dustin A. Deming, Philip Agop Philip, Theodore S. Hong, Yesenia Rojas-Khalil, Jonathan M. Loree, Norman Wolmark, Greg Yothers, Thomas J. George, and Christopher Hanyoung Lieu. Journal of Clinical Oncology (2023) 41:16_suppl, TPS3634-TPS3634.
