The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines.GROUP II (ctDNA NOT DETECTED): Patients undergo active surveillance.Īfter completion of study treatment, patients are followed up at 12 months and then every 6 months for 2 years. GROUP I (ctDNA DETECTED): At the discretion of the investigator, patients receive either oxaliplatin intravenously (IV) over 2 hours on day 1, leucovorin IV over 2 hours on day 1, and fluorouracil IV bolus over 2-4 minutes on day 1 and then by continuous IV over 46-48 hours repeated every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity or oxaliplatin IV over 2 hours on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-14 repeated every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

OUTLINE: Patients are randomized to 1 of 2 arms.ĪRM I (BLOOD STORED AND TESTED FOR ctDNA LATER): Patients undergo active surveillance.ĪRM II (BLOOD TESTED FOR ctDNA AT BASELINE): Patients are assigned to 1 of 2 groups. To evaluate performance of a ctDNA assay after incorporation of patient tumor and peripheral blood mononuclear cells. To model the cost effectiveness of the use of ctDNA versus standard of care in this setting. To characterize genomic profiles associated with recurrence using a ctDNA assay in patients with resected stage IIA colon cancer. To describe the association of quantitative ctDNA levels with time to event outcomes (RFS, OS, and TTR). To estimate the rate of compliance with adjuvant chemotherapy and/or active surveillance for patients with resected stage IIA colon cancer. To estimate time-to-event outcomes (overall survival, recurrence-free survival, and time to recurrence ) by ctDNA marker status and treatment for patients with resected stage IIA colon cancer.

To describe the prevalence of detectable ctDNA in patients with stage IIA colon cancer following surgical resection. To compare recurrence-free survival (RFS) in 'ctDNA detected' patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer. To compare the rate of ctDNA clearance in 'ctDNA detected' patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer.

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