At a glance
ClinicalIndex Comparison Record- ✓Age 19-75 years
- ✓Adenocarcinoma of colon confirmed by histology
- ✓Stage II-III colon cancer (AJCC 8th edition; Stage II must be high-risk with multiple recurrence factors)
- ✓Completed 6 cycles of FOLFOX or 4 cycles of CAPOX adjuvant chemotherapy after R0 resection
- ✕Pregnant or lactating women
- ✕Positive pregnancy test at baseline (postmenopausal status requires ≥12 months amenorrhea)
- ✕Reproductive-age patients unwilling to use contraception during and 6 months (female) or 3 months (male) after treatment
- ✕Clinically significant cardiac disease: unstable angina, symptomatic CAD, CHF, NYHA >II arrhythmia, or ACS/MI within 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Controlled Phase III Trial of Treatment Intensification in Stage II-III Colon Cancer Patients With Positive MRD During Adjuvant Chemotherapy
In Brief
A Phase 3 clinical trial evaluating mFOLFIRINOX-FOLFIRI intensified chemotherapy and FOLFOX or CAPOX adjuvant chemotherapy for Colon Cancer. Currently recruiting, targeting 236 participants across 3 sites.
Detailed Summary
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
Study Details
Timeline
Interventions
(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
1. 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