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.)
Pregnant or lactating women
Pregnant women who had a positive pregnancy test at the time of the baseline examination (postmenopausal women must be amenable for at least 12 months to be considered non-fertility)
Sexually active men and women of reproductive age who are unwilling to use contraception throughout the study treatment and for a period of 6 months (female) or 3 months (male) following the discontinuation of study treatment
Clinically significant heart condition [unstable angina requiring medication, symptomatic coronary artery disease, congestive heart failure, or significant heart arrhythmia above NYHA II, or acute coronary syndrome, including myocardial infarction within the last 6 months]
Parallel
mFOLFIRINOX-FOLFIRI intensified chemotherapy
Drug(1) Modified FOLFIRINOX (mFOLFIRINOX) regimen: 6 cycles every 2 weeks * Oxaliplatin 85mg/m2 IV infusion over 120 min D1 * Leucovorin 400mg/m2 IV (concurrently with oxaliplatin) * Irinotecan 150mg/m2 IV infusion over 60-90 min D1 * 5-fluorouracil 2,400mg/m2 IV infusion continuously over 46-48h D1-2
FOLFOX or CAPOX adjuvant chemotherapy
Drug1. FOLFOX regimen: 6 cycles every 2 weeks * Oxaliplatin 85mg/m2 IV infusion over 120 min D1 * Leucovorin 400mg/m2 IV infusion over 120 min (concurrently with oxaliplatin) * 5-fluorouracil 400mg/m2 IV bolus D1 * 5-fluorouracil 2,400mg/m2 IV infusion continuously over 46-48h D1-2 or 2. CAPOX regimen: 4 cycles every 3 weeks * Oxaliplatin 130mg/m2 IV infusion over 120 min D1 * Capecitabine 1,000mg/m2 PO bid D1-14
3-year disease-free survival rate
The rate refers to cases that see first tumor metastasis or recurrence or death of any cause from randomization
Circulating tumor DNA (ctDNA) clearance rate
The proportion of patients with circulating tumor DNA clearance after 36months study treatment.
5-year overall survival rate (5y-OS rate)
Overall survival is defined as the time from beginning of study treatment until death due to any cause.
Treatment-Related Adverse Events
The number of patients with adverse events and the severity according to CTCAE v5.0.
EORTC QLQ-C30 scale
Using the EORTC QLQ-C30 scale (European Organization for Research on Treatment of Cancer Quality of Life Questionnaire-Core 30) to evaluate the quality of life of patients.
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