A Randomized Controlled Phase III Trial of Treatment Intensification in Stage II-III Colon Cancer Patients With Positive MRD During Adjuvant Chemotherapy
This study is a prospective, open-label, randomized phase 3 clinical trial. It aims to investigate if the early introduction of intensified chemotherapy (3 months of modified FOLFIRINOX) improves the 3-year disease-free survival rate compared to standard treatment (FOLFOX/CAPOX for an additional three months to complete six months of standard adjuvant chemotherapy) in patients with stage 2-3 colon cancer in whom ctDNA MRD in the part 1 study remained positive during adjuvant FOLFOX/CAPOX chemotherapy
• Patients who willingly consented and signed the informed consent form to participate in the study
• Age range of 19 to 75 years
• Adenocarcinoma of colon confirmed by histology
• Patients with stage II-III colon cancer as defined by the American Joint Committee on Cancer's eighth edition (Stage II cancer is limited to patients who are at a high risk, with more than one risk factor for recurrence.)
• Patients who have completed the sixth cycle of FOLFOX or the fourth cycle of CAPOX adjuvant chemotherapy for colon cancer following radical resection (R0 resection)
• A ctDNA test performed 3 to 6 weeks after surgery reveals a positive MRD
• ECOG performance scale of 0-1 (only 1 is allowed for 70-75 years old)
• Adequate bone marrow function \[ANC ≥1,300/LL, platelets ≥75,000/LL, hemoglobin ≥8.0g/dL (may be eligible in study if intermittent transfusion is required)\]
• Appropriate liver function (total bilirubin ≤1.5xULN, AST and ALT ≤3xULN)
⁃ Appropriate renal function (serum creatine ≤1.5xULN, renal clearance rate ≥50 ml/min)
⁃ Patients who are deemed to understand the study protocol and are willing to participate in the trial until it is completed