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Platform Study of Circulating Tumor DNA Directed Adjuvant Chemotherapy in Colon Cancer (KCSG CO22-12)
Sponsor: Seoul National University Hospital
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
Official title: A Randomized Controlled Phase III Trial of Treatment Intensification in Stage II-III Colon Cancer Patients With Positive MRD During Adjuvant Chemotherapy
Key Details
Gender
All
Age Range
19 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
236
Start Date
2022-12-15
Completion Date
2030-09-30
Last Updated
2026-08-10
Healthy Volunteers
No
Conditions
Interventions
mFOLFIRINOX-FOLFIRI intensified chemotherapy
(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
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
Locations (13)
Dong-A University Hospital
Busan, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
National Cancer Center
Goyang, South Korea
Chonnam National University Hwasun Hospital
Hwasun, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea