NCT05534087

Platform Study of Circulating Tumor DNA Directed Adjuvant Chemotherapy in Colon Cancer (KCSG CO22-12)

A Randomized Controlled Phase III Trial of Treatment Intensification in Stage II-III Colon Cancer Patients With Positive MRD During Adjuvant Chemotherapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DRUG	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
DRUG	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

Timeline

• Start date: 2022-12-15
• Primary completion: 2028-09-30
• Completion: 2030-09-30
• First posted: 2022-09-09
• Last updated: 2024-11-29

Locations

3 sites across 1 country: South Korea