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Closed to Accrual: CO29

Closed to Accrual: C029

The CO29 trial: Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Sutdy, AGITG DYNAMIC-III has closed to accrual. The study reached its overall accrual target of 1000 patients, 209 of which were randomized by Canadian sites.

Primary objective: To evaluate the impact of a de-escalation/escalation treatment strategy using ctDNA-informed management. The ctDNA positive and negative cohorts will be evaluated separately: (a) For ctDNA negative patients: de-escalation treatment strategy is non-inferior to standard of care (b) For the ctDNA positive patients: escalation treatment strategy is superior to standard of care. Secondary objectives: To demonstrate (1) ctDNA-informed adjuvant therapy approach will not compromise RFS in patients with NEGATIVE post-op ctDNA; (2) an acceptable rate of de-escalation in the ctDNA-informed negative cohort; (3) 3-year RFS rates between ctDNA-informed therapy and standard of care in patients with POSITIVE post-op ctDNA; (4) OS between ctDNA-informed therapy and standard of care in patients with POS & NEG post-op ctDNA; (5) end of treatment ctDNA results with RFS and OS; (6) feasibility of adjuvant chemo strategy based on post-op ctDNA results; (7) Heath economic impact

For more information please visit the CCTG CO29 members trial page.