Wednesday, February 17, 2021 The CCTG CO29 (AGITG CTDNA-08) - Circulating Tumor DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multi-centre Phase II/III Randomised Controlled Study (DYNAMIC III) has been centrally activated. Eligibility: Patients aged 18 years of age - Subjects with curatively resected stage III (Any T, N1 or N2, M0) colorectal cancer - Patients with rectal cancer will be eligible unless they have had pre-operative combined chemotherapy and radiotherapy, or are scheduled for post-operative combined chemotherapy and radiotherapy. All rectal cancer patients must have had TME type surgery with negative (R0) resection margins. - A representative tumour sample is available for molecular testing up to 6 weeks after surgery (refer to section 9.1.1 for a more specific timeframe) - Fit for at least single agent fluoropyrimidine adjuvant chemotherapy - ECOG performance status 0-2 - No metastatic disease Objectives: 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 CO29 members trial page.
