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IRinotecan and Oxaliplatin for Colon Cancer in Adjuvant Setting

NCT02967289 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 792

Last updated 2025-11-17

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Irinotecan

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

DRUG

Folfox Protocol

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

Sponsors & Collaborators

  • Canadian Cancer Trials Group

    collaborator NETWORK

  • GONO GROUP

    collaborator UNKNOWN

  • UNICANCER

    lead OTHER

Principal Investigators

  • Jaafar BENNOUNA, Professor · Hôpital FOCH, SURESNES

  • Julien TAIEB, Professor · Hôpital Européen Georges-Pompidou, PARIS

  • Thierry ANDRE, Professor · AP-HP Hôpital Saint-Antoine, PARIS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-27
Primary Completion
2025-06-15
Completion
2025-07-15

Countries

  • Canada
  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02967289 on ClinicalTrials.gov