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New chemo cocktail tested to prevent colon cancer return

NCT ID NCT02967289

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a stronger chemotherapy combination (mFOLFIRINOX) works better than the standard one (mFOLFOX) for people with high-risk stage III colon cancer after surgery. About 792 patients took part across multiple countries. The goal was to see if the stronger combo could keep the cancer from coming back longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mFOLFIRINOX (combination of 5-fluorouracil, folinic acid, irinotecan, and oxaliplatin) versus mFOLFOX (oxaliplatin, folinic acid, and 5-fluorouracil)
What this could lead to
If successful, this could establish a more effective chemotherapy option to reduce the risk of cancer returning after surgery for high-risk stage III colon cancer.
What could go wrong
This is a completed phase III trial, so results are available but may show no significant benefit or increased side effects with the more intensive regimen. The findings apply only to a specific high-risk group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

792 people

The number who actually took part.

Started

Mar 2017

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

DIAGNOSIS AND INCLUSION CRITERIA: 1. Patient ≥18 years and \< 75 years 2. Patient ≥18 years and \<71 years must have an ECOG ≤1 - Patients ≥71 years and \< 75 years must have an ECOG = 0 3. Pathologically confirmed high-risk stage III colon adenocarcinoma, restricted to pT4N1 or pT1-4N2 tumor. 4. Curative R0 surgical resection. 5. Patients who have undergone surgery for colon cancer, defined as a tumor location \>12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery (high rectum), without gross or microscopic evidence of residual disease after surgery with curative intent 6. Start of study drug treatment has to be performed less than 56 days after surgery. 7. No prior chemotherapy. 8. No prior abdominal or pelvic irradiation. 9. Patient with adequate organ function: * Absolute neutrophil count (ANC) ≥ 2 x 109/L * Haemoglobin ≥9 g/dL * Platelets (PTL) ≥100 x 109/L * AST/ALT ≤2.5 x ULN * Alkaline phosphatase ≤2.5 x ULN * Total Bilirubin ≤1.5 x ULN (Upper Limit of Normal) * Creatinine clearance ≥50 mL/min (Cockcroft and Gault formula) * Kalemia, magnesemia, calcemia ≥ 1 LLN (Lower Limit of Normal) * Carcinoembryonic antigen (CEA) ≤10ng/mL after surgery (during screening period) 10. Adequate contraception if applicable. 11. Patient able and willing to comply with study procedures as per protocol 12. Patient able to understand and willing to sign and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures 13. Public or private health insurance coverage 14. Life expectancy of \> or = at 5 years 15. Uracilemia \< 16 ng/ml (only for french centers) Exclusion Criteria: 1. 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 2. Metastatic disease 3. Presence of inflammatory bowel disease and/or ileus 4. Known hypersensitivity reaction to any of the components of study treatments. 5. Pregnancy (absence to be confirmed by β-hCG test) or breast-feeding period 6. 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) 7. Previous malignancy in the last 5 years except curative treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix 8. Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent 9. 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. 10. Any significant disease which, in the investigator's opinion, would exclude the patient from the study. 11. 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). 12. Patients already included in another therapeutic trial involving an experimental drug

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, Canada

  • CHD de Vendée

    La Roche-sur-Yon, France

  • CHP Saint Grégoire

    Saint-Grégoire, France

  • Centre Hospitalier Annecy Genevois

    Pringy, France

  • Centre hospitalier de l'Université de Montréal

    Montreal, Quebec, Canada

  • Ch Emile Roux

    Le Puy-en-Velay, France

  • Clinique de la Côte d'Emeraude

    St-Malo, France

  • Hopital Charles LeMoyne

    Greenfield Park, Quebec, Canada

  • Hospices civils de Lyon - Hôpital Edouard Herriot

    Lyon, France

  • Hôpital Européen Georges Pompidou

    Paris, France

  • Hôpital Saint Antoine

    Paris, France

  • Hôpital privé Jean Mermoz

    Lyon, France

  • Icm Val D'Aurelle

    Montpellier, France

  • Institut Jean Godinot

    Reims, France

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

    Angers, France

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

    Nantes, France

  • The PEI Cancer Treatment Centre Queen Elizabeth Hospital

    Charlottetown, Prince Edward Island, Canada

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Other studies related to the condition(s) this trial covers.