RecruitingPhase 3NCT05534087

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

Sponsor

Seoul National University Hospital

Enrollment

236 participants

Start Date

Dec 15, 2022

Study Type

INTERVENTIONAL

Conditions

Colon Cancer

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

Eligibility

Min Age: 19 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is using a blood-based cancer DNA test (circulating tumor DNA, or ctDNA) to guide additional chemotherapy decisions after surgery for colon cancer. Patients who still have detectable cancer DNA in their blood after completing standard chemotherapy may benefit from additional treatment. **You may be eligible if...** - You are 19–75 years old with confirmed stage II or III colon adenocarcinoma - You have had complete (curative) surgical removal of the colon cancer - You have completed 6 cycles of FOLFOX or 4 cycles of CAPOX chemotherapy after surgery - A ctDNA test done 3–6 weeks after surgery showed a positive (detectable) result, indicating minimal residual disease - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are sexually active without using effective contraception - Your ctDNA test was negative after surgery - You are older than 75 or have poor functional status Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGmFOLFIRINOX-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

DRUGFOLFOX 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