RecruitingPhase 2Phase 3NCT05179889

Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer

mFOLFIRINOX Versus mFOLFOX 6 as Adjuvant Treatment for High Risk Stage III (pT4N1/2 or pTanyN2) Colon Cancer: Multicenter, Open Labeled, Randomized, Phase II Study

Sponsor

Chungnam National University Hospital

Enrollment

308 participants

Start Date

Jul 6, 2021

Study Type

INTERVENTIONAL

Conditions

Colon Cancer Stage III

Summary

A multicenter, open labeled randomized, phase II trial comparing mFOLFIRINOX and mFOLFOX6 as adjuvant treatment for high risk stage III (pT4N1/2 or pTanyN2) colon cancer

Eligibility

Min Age: 20 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a more intensive chemotherapy regimen (mFOLFIRINOX) works better than the standard regimen (FOLFOX or CAPOX) after surgery to reduce the chance of high-risk stage III colon cancer coming back. **You may be eligible if:** - You are between 20 and 75 years old (or 20–70 with good performance status, or 71–75 if you are very fit) - You have been diagnosed with high-risk stage III colon cancer (cancer has spread to nearby lymph nodes and involved deeper tissue) confirmed by pathology - You have had a successful surgery to remove all visible cancer (R0 resection) within the past 60 days - Your blood counts, liver, and kidney function are within acceptable ranges - Your expected lifespan is at least 5 years **You may NOT be eligible if:** - Cancer has spread to distant organs - You have rectal cancer requiring radiation - You had serious surgical complications - You have inflammatory bowel disease (Crohn's or ulcerative colitis) - You are pregnant or breastfeeding - You have a hereditary colon cancer syndrome (like Lynch syndrome or FAP) 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

Irinotecan 150 mg/m2 IV day 1, oxaliplatin 85 mg/m2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg/m2 IV day 1, 5-FU 1200 mg/m2/d IV x 2 days (total 2400 mg/m2 over 48 hours) continuous infusion\] 12 cycles per 2 weeks mFOLFOX 6 \[Oxaliplatin 85 mg/m2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg/m2 IV day 1, 5-FU 400 mg/m2 IV bolus day 1, 5-FU 1200 mg/m2/d IV x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion, 12 cycles per 2 week

DRUGmFOLFOX 6

Oxaliplatin 85 mg/m2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg/m2 IV day 1, 5-FU 400 mg/m2 IV bolus day 1, 5-FU 1200 mg/m2/d IV x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion, 12 cycles per 2 weeks