At a glance
ClinicalIndex Comparison Record- ✓Age 20-70 years with ECOG ≤ 2
- ✓Age 71-75 years with ECOG = 0
- ✓Pathologically confirmed high-risk stage III colon adenocarcinoma (pT4N1 or pTanyN2)
- ✓Curative radical resection (R0) within 60 days before randomization
- ✕Distant metastasis
- ✕Middle or lower rectal cancer requiring radiotherapy
- ✕Postoperative complication of Clavien-Dindo grade ≥3
- ✕Underlying disease or postoperative condition contraindicated for chemotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating mFOLFIRINOX and mFOLFOX 6 for Colon Cancer Stage III. Currently recruiting, targeting 308 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
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
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