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
About 25% of resectable high-risk stage 2 or stage 3 colon cancers are known to relapse despite standard treatments, including radical resection and adjuvant chemotherapy. Using circulating tumor DNA (ctDNA)-based minimal residual cancer (MRD) detection technology, patients whose MRD is not eradicated after adjuvant chemotherapy could be identified. Early introduction of intensified chemotherapy for this group of patients could prolong survival time and increase cure rates. This study is part of the Platform Study of Circulating Tumor DNA Directed Adjuvant Chemotherapy in Colon Cancer (CLADIA Colon Cancer). Part 1 of the platform study (Prospective Observational Study of ctDNA Monitoring During Adjuvant) is a large-scale, prospective observational study that follows ctDNA up to three years after resection in about 1,200 patients with stage 2-3 colon cancer. This study (Part 2) aims to study the efficacy of early intensified chemotherapy (3 months of modified FOLFIRINOX ) 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
236
(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
Dong-A University Hospital
Busan, South Korea
RECRUITINGKyungpook National University Chilgok Hospital
Daegu, South Korea
RECRUITINGNational Cancer Center
Goyang, South Korea
RECRUITINGChonnam National University Hwasun Hospital
Hwasun, South Korea
RECRUITINGSeoul National University Bundang Hospital
Seongnam, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGChung-Ang University Hospital
Seoul, South Korea
RECRUITINGKorea University Guro Hospital
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITING...and 3 more locations
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
Time frame: Through completion of follow-up (estimated to be 36 months)
Circulating tumor DNA (ctDNA) clearance rate
The proportion of patients with circulating tumor DNA clearance after 36months study treatment.
Time frame: The data of ctDNA clearance rate will be collected at 10 time points
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.
Time frame: Through completion of follow-up (estimated to be 60 months)
Treatment-Related Adverse Events
The number of patients with adverse events and the severity according to CTCAE v5.0.
Time frame: Through completion of follow-up (estimated to be 36 months)
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.
Time frame: Through completion of follow-up (estimated to be 36 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.