IRinotecan and Oxaliplatin for Colon Cancer in Adjuvant Setting

Conditions

• Colon Cancer (High-risk Stage III: pT4N1 or pT1 to 4 N2)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Irinotecan — DRUG
  every 14 days, 12 cycles, 24 weeks, new cycle beginning on day 15: irinotecan (Campto®) 180 mg/m² on D1, IV infusion over 90 minutes to begin 30 min after folinic acid infusion is started
• Folfox Protocol — DRUG
  every 14 days, 12 cycles, 24 weeks, new cycle beginning on day 15: oxaliplatin (Eloxatin®) 85 mg/m² on D1, IV infusion over 2 hours, followed by folinic acid 400 mg/m² (racemic mixture) (or 200 mg/m² if L-folinic acid) IV infusion over 2 hours 5-FU 2400 mg/m²/h IV continuous infusion over 46 hours starting at the end of folinic acid infusion

Study Details

The trial is a phase III, multicenter, open-labeled randomized trial comparing the association of 5-fluorouracil (5-FU), folinic acid, irinotecan, and oxaliplatin (mFOLFIRINOX) versus oxaliplatin, folinic acid, and 5-FU (mFOLFOX 6) chemotherapy protocols in patients with high-risk stage III colon cancer in the adjuvant setting.

Key Dates

Start date

Mar 27, 2017

Status verified

Sep 2024

Primary completion

Jun 15, 2025

Completion

Jul 15, 2025

Study Design

Enrollment

792 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A
  mFOLFIRINOX Folfox Protocol + Irinotecan
• Active Comparator: Arm B
  mFOLFOX 6 Folfox Protocol

Primary Outcome Measure

Disease Free Survival (DFS) [ Time Frame: 3 YEARS after inclusion ]