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Patients who have had a two-stage surgical procedure, to first provide a decompressive colostomy and then in a later procedure to have the definitive surgical resection, are eligible.\n\nThe resected tumor specimen and a blood specimen from patients with Stage IIB, IIC, or Stage III colon cancer must have central testing for ctDNA using the Signatera™ assay by Natera (after Step 1\u002FStudy entry and before Step2\u002FRandomization). Patient must have sufficient tissue to meet protocol requirements. This blood specimen for the Signatera assay must be collected after surgery (and recommended at least 14 days post surgery).\n\nTumor must be documented as microsatellite stable or have intact mismatch repair proteins through CLIA-approved laboratory testing. Patients whose tumors are MSI-H or dMMR are excluded.\n\nThe treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan).\n\nThe interval between surgery (post-operative Day 7) and Step 1\u002FStudy entry must be no more than 60 days. NOTE: Step 1\u002FStudy Entry may occur as early as post operative Day 7, but it cannot occur beyond 60 days from the actual date of the patient's surgery.\n\nAvailability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling.\n\nAdequate hematologic function within 28 days before Step 1\u002FStudy entry defined as follows:\n\n* Absolute neutrophil count (ANC) must be greater than or equal to 1500\u002Fmm3;\n* Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.\n* BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.\n* Platelet count must be greater than or equal to 100,000\u002Fmm3; and\n* Hemoglobin must be greater than or equal to 9 g\u002FdL.\n\nAdequate hepatic function within 28 days before Step 1\u002FStudy entry defined as follows:\n\n* total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and\n* alkaline phosphatase must be less than 2.5 x ULN for the lab; and\n* AST and ALT must be less than 2.5 x ULN for the lab.\n\nAdequate renal function within 28 days before Step 1\u002FStudy entry defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL\u002Fmin using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab.\n\nFor Women Creatinine Clearance (mL\u002Fmin) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg\u002FdL) For Men Creatinine Clearance (mL\u002Fmin) = (140 - age) x weight (kg) 72 x serum creatinine (mg\u002FdL) NOTE: Adjusted body weight (AdjBW) should be used for patients that have BMI greater than or equal to 28 (less than or equal to 30% above IBW).\n\nHIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n\nPregnancy test (urine or serum according to institutional standard) done within 14 days before Step 1\u002FStudy entry must be negative (for women of childbearing potential only).\n\nPatients receiving a coumarin-derivative anticoagulant must agree to weekly monitoring of INR if they are randomized to Arm 1 or Arm 3 and receive capecitabine.\n\nEligibility Criteria for Cohort A Arm-2 patients on Second Randomization\n\nPatient must have developed a ctDNA +ve assay during serial monitoring.\n\nPatient's willingness to be re-randomized affirmed.\n\nThe patient must continue to have an ECOG performance status of 0 or 1.\n\nNo radiographic evidence of overt metastatic disease.\n\nPregnancy test (urine or serum according to institutional standard) done within 14 days before second randomization must be negative (for women of childbearing potential only).\n\nAdequate hematologic function within 28 days before second randomization defined as follows:\n\n* Absolute neutrophil count (ANC) must be greater than or equal to 1500\u002Fmm3;\n* Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.\n* BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.\n* Platelet count must be greater than or equal to 100,000\u002Fmm3; and\n* Hemoglobin must be greater than or equal to 9 g\u002FdL.\n\nAdequate hepatic function within 28 days before second randomization defined as follows:\n\n* total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and\n* alkaline phosphatase must be less than 2.5 x ULN for the lab; and\n* AST and ALT must be less than 2.5 x ULN for the lab.\n\nAdequate renal function within 28 days before second randomization defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL\u002Fmin using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab.\n\nFor Women Creatinine Clearance (mL\u002Fmin) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg\u002FdL) For Men Creatinine Clearance (mL\u002Fmin) = (140 - age) x weight (kg) 72 x serum creatinine (mg\u002FdL)\n\nExclusion Criteria:\n\nColon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.).\n\nPathologic, clinical, or radiologic overt evidence of metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected.\n\nTumor-related bowel perforation.\n\nHistory of prior invasive colon malignancy, regardless of disease-free interval.\n\nHistory of bone marrow or solid organ transplantation (regardless of current immunosuppressive therapy needs). Bone grafts, skin grafts, corneal transplants and organ\u002Ftissue donation are not exclusionary.\n\nAny prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer (e.g., primary colon adenocarcinomas for which treatment with neoadjuvant chemotherapy and\u002For radiation is warranted are not permitted). EXCEPTION: one cycle of chemotherapy (regimen per treating physicians' discretion - 5-FU or capecitabine with or without oxaliplatin) is allowed but not required after consent. The optional cycle of chemotherapy should be started greater than or equal to 4 weeks from surgery and while awaiting Step 2 randomization.\n\nOther invasive malignancy within 5 years before Step 1\u002FStudy entry. Exceptions are colonic polyps, non-melanoma skin cancer or any carcinoma-in-situ.\n\nSynchronous primary rectal and\u002F or colon cancers.\n\nPatients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n\nSensory or motor neuropathy greater than or equal to grade 2, according to CTCAE v5.0.\n\nBlood transfusion within two weeks before collection of blood for central ctDNA testing.\n\nActive seizure disorder uncontrolled by medication.\n\nActive or chronic infection requiring systemic therapy.\n\nKnown homozygous DPD (dihydropyrimidine dehydrogenase) deficiency.\n\nPatients known to have Gilbert's Syndrome or homozygosity for UGT1A1\\*28 polymorphism.\n\nPregnancy or lactation at the time of Step 1\u002FStudy entry.\n\nCo-morbid illnesses or other concurrent disease that would make the patient inappropriate for entry into this study (i.e., unable to tolerate 6 months of combination chemotherapy or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or prevent required follow-up).\n\nIneligibility Criteria for Cohort A Arm-2 patients on Second Randomization\n\nPregnancy or lactation at the time of randomization.\n\nNo longer a candidate for systemic chemotherapy (FOLFOX, CAPOX, and mFOLFIRINOX) in the opinion of the treating investigator.","ALL","18 Years",{"count":12327,"type":12328},1912,"ESTIMATED","INTERVENTIONAL",[12331,12332],"PHASE2","PHASE3","This Phase II\u002FIII trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.",[12335],"Stage III Colon Cancer",[12337,12338,12339,12340,12341,12342,12343,12344,49,12345,12346,12347,12348,12349,12350],"ctDNA positive","ctDNA negative","Adjuvant Chemotherapy","Natera","Signatera","mFOLFOX6","Stage III","CAPOX","Oxaliplatin","5-Fluorouracil (5-FU)","Capecitabine","Leucovorin","Irinotecan","Stage II","2026-07-01",{"date":12353,"type":12354},"2026-07-02","ACTUAL",{"date":12356,"type":12354},"2022-07-08",{"date":12358,"type":12328},"2030-03-10",{"name":5,"class":6},1063]