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Colon Cancer (High-risk Stage III: pT4N1 or pT1 to 4 N2)Phase 3IROCASNCT02967289

IRinotecan and Oxaliplatin for Colon Cancer in Adjuvant Setting

A Phase 3 study testing Irinotecan and Folfox Protocol in people with Colon Cancer (High-risk Stage III: pT4N1 or pT1 to 4 N2), run by UNICANCER at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Irinotecan and Folfox Protocol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
792 participants
Where
17 sitesin 2 countries
Study dates
27 Mar 2017to 15 Jul 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start. Incompletely healed wounds or anticipation of the need for major surgical procedure during the course of the study
  • Metastatic disease
  • Presence of inflammatory bowel disease and/or ileus
  • Known hypersensitivity reaction to any of the components of study treatments.
  • Pregnancy (absence to be confirmed by β-hCG test) or breast-feeding period
  • Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia (for men: QTc ≥450 msec, for women: QTc ≥470 msec)
Show all 12Show fewer
  • Previous malignancy in the last 5 years except curative treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
  • Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
  • History or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ grade 1 Common Toxicity Criteria for Adverse Events (CTCAE) v4.03.
  • Any significant disease which, in the investigator's opinion, would exclude the patient from the study.
  • Patient with a DPD deficiency or UGT1A1 homozygous 7/7; the test should be done for all patients before 5-FU administration, according to ANSM communication regarding recommendation about high risk of no testing DPD in patient before 5-FU administration; (Appendices 8 to 11).
  • Patients already included in another therapeutic trial involving an experimental drug

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

France13 sites

  • Institut de Cancérologie de l'Ouest -site Paul Papin

    Angers

  • CHD de Vendée

    La Roche-sur-Yon

  • Ch Emile Roux

    Le Puy-en-Velay

  • Hospices civils de Lyon - Hôpital Edouard Herriot

    Lyon

  • Hôpital privé Jean Mermoz

    Lyon

  • Icm Val D'Aurelle

    Montpellier

  • Institut de Cancérologie de l'Ouest -site René Gauducheau

    Nantes

  • Hôpital Européen Georges Pompidou

    Paris

  • Hôpital Saint Antoine

    Paris

  • Centre Hospitalier Annecy Genevois

    Pringy

  • Institut Jean Godinot

    Reims

  • CHP Saint Grégoire

    Saint-Grégoire

  • Clinique de la Côte d'Emeraude

    St-Malo

Other trials in France

Canada4 sites

  • The PEI Cancer Treatment Centre Queen Elizabeth Hospital

    Charlottetown, Prince Edward Island

  • Hopital Charles LeMoyne

    Greenfield Park, Quebec

  • Centre hospitalier de l'Université de Montréal

    Montreal, Quebec

  • Allan Blair Cancer Centre

    Regina, Saskatchewan

Other trials in Canada

About this study

Official title: A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for High-risk Stage III Colon Cancer in Adjuvant Setting

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.

Read the detailed description

After inclusion and non-inclusion criteria have been fulfilled and the patient consent has been obtained, the patient will be included and randomized in the trial. The maximum delay allowed between the signature of the consent form by the patient and the randomization in the study is 28 days.

The randomization procedure using minimization method will allocate the treatments mFOLFIRINOX or mFOLFOX 6 with a 1:1 ratio, and will be stratified by the following criteria:

  • Perforation or urgent surgery versus no perforation and no urgent surgery.
  • T1-T3N2 vs T4aN1 versus T4bN1 versus T4N2.
  • Right colon (right of splenic flexure) vs left colon.
  • Country (France vs Canada vs Italy). Patient eligible and who have signed the informed consent will be randomized in one of the two treatments arms and will receive every 14 days their treatment for a duration of 12 cycles.

Arm A: mFOLFIRINOX Arm B: mFOLFOX 6

Being tested
Irinotecan, Folfox Protocol
Keywords
colon, cancer, stage 3, high-risk, mFolfirinox, mFolfox6, adjuvant
Medical subject headings
Colonic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IrinotecanDrug

    Also called Campto

    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 ProtocolDrug

    Also called acid folinic + oxaliplatine + 5-FU

    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 groups in NCT02967289
Study groupRoleWhat they receive
Arm AExperimentalmFOLFIRINOX Folfox Protocol + Irinotecan
Receives: Drug: Irinotecan; Drug: Folfox Protocol
Arm BActive comparatormFOLFOX 6 Folfox Protocol
Receives: Drug: Folfox Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Free Survival (DFS)

    DFS :

    defined as the time from the date of randomization up to the date of:

    • first local, regional or distant relapse;
    • second colorectal cancer;
    • death from any cause included treatment-related death.

    Measured: 3 YEARS after inclusion

Secondary outcomes (3)

  1. Disease Free Survival

    DFS :

    defined as the time from the date of randomization up to the date of:

    • first local, regional or distant relapse;
    • second colorectal cancer;
    • death from any cause included treatment-related death.

    Measured: 2 YEARS after inclusion

  2. Overall Survival

    Overall Survival (OS) is defined as the time from the date of randomization to the date of documented death from any cause

    Measured: 5 YEARS after inclusion

  3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Safety of the study treatment will be assessed on occurrence of Adverse Events (AEs), intake of concomitant treatments, per-treatment arising changes in physical examination, vital signs (blood pressure, pulse rate and body temperature), ECG, and clinical laboratory tests (biochemistry, haematology). Safety parameters will be graded based on NCI CTCAE v4.03 classification.

    The following parameters will be particularly followed:

    The incidence of haematological toxicities (grade 3-4, in particular neutropenia and febrile neutropenia); The incidence of GI toxicities, in particular diarrhea; The incidence of peripheral neuropathy.

    Measured: 2 YEARS after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2016 (estimated)
  2. Study start27 Mar 2017
  3. Primary completion15 Jun 2025
  4. Study completion15 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The trial is a phase III, multicenter, open-labeled randomized trial comparing the association 5-fluorouracil, folinic acid, irinotecan and oxaliplatin (mFOLFIRINOX) versus oxaliplatin, folinic acid, 5FU (mFOLFOX 6) chemotherapy protocols in patients with high-risk stage III colon cancer in the adjuvant setting.
Masking
None (open label)
Enrolment
792 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02967289
Sponsor's protocol ID
UC-0110/1609_PRODIGE52/UCGI29
Other IDs
2016-001491-29, 2016
Acronym
IROCAS
Status last verified
Sep 2024
First submitted
9 Nov 2016
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

Publications

  • Bennouna J, Andre T, Martin E, Cremolini C, Gill S, Asmis T, Kavan P, Mitry E, Hiret S, Mineur L, Artru P, Perret C, Bouche O, Touchefeu Y, Goldenberg B, Dupuis O, Lonardi S, Chibaudel B, Castanie H, Coutzac C, Bauguion L, Guardiola E, Benmaziane A, Barriere J, Chen E, Simmet V, Allegrini G, Marmorino F, Pezzella V, Monard L, Campion L, O'Callaghan C, Taieb J. A randomised phase III trial of adjuvant treatment intensification with mFOLFIRINOX versus mFOLFOX6 in high-risk stage III colon cancer: Results of the international IROCAS study. Ann Oncol. 2026 Oct 25:S0923-7534(26)06886-9. doi: 10.1016/j.annonc.2026.10.104. Online ahead of print.

    PubMed 42927853

  • Bennouna J, Andre T, Campion L, Hiret S, Miglianico L, Mineur L, Touchefeu Y, Artru P, Asmis T, Bouche O, Borde F, Kavan P, Lam YH, Rajpar LS, Emile JF, Jouffroy C, Gill S, Taieb J. Rationale and Design of the IROCAS Study: Multicenter, International, Randomized Phase 3 Trial Comparing Adjuvant Modified (m) FOLFIRINOX to mFOLFOX6 in Patients With High-Risk Stage III (pT4 and/or N2) Colon Cancer-A UNICANCER GI-PRODIGE Trial. Clin Colorectal Cancer. 2019 Mar;18(1):e69-e73. doi: 10.1016/j.clcc.2018.09.011. Epub 2018 Oct 19.

    PubMed 30415988

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Irinotecan and Folfox Protocol in people with Colon Cancer (High-risk Stage III: pT4N1 or pT1 to 4 N2), run by UNICANCER at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free Survival (DFS) (time frame: 3 YEARS after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02967289, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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