Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

• Patients must have histologically/pathologically confirmed colon adenocarcinoma (T1-3, N1/N1c) with R0 resection accordingly to AJCC 8th edition criteria. NOTE: Patients with pathologic stages II or IIIC colon adenocarcinoma with R0 resection who have a commercially obtained Signatera™ ctDNA+ve assay result post-operatively meeting all timelines and eligibility requirements otherwise, are eligible for enrollment and inclusion in Cohort B.
• No radiographic evidence of overt metastatic disease
• Distal extent of tumor must be greater than or equal to 12cm from the anal verge
• Must have had curative resection (en bloc)
• Resected tumor specimen and blood must have central testing for ctDNA useing the Signatera assay
• Must be microsatellite stable or have intact mismatch proteins
• No more than 60 days post surgery to study entry
• No other invasive malignancy within 5 years
• No known active cardiac disease

• Primary
  • ctDNA positive status
  • DFS
• Secondary
  • Baseline post-surgery ctNDA positivity rate
  • OS
  • Time to recurrence
  • Compliance with therapy