New chemo cocktail tested to prevent colon cancer return
NCT ID NCT02967289
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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792 people
The number who actually took part.
- Started
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Mar 2017
- Finished
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Jul 2025
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
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CHD de Vendée
La Roche-sur-Yon, France
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CHP Saint Grégoire
Saint-Grégoire, France
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Centre Hospitalier Annecy Genevois
Pringy, France
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Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
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Ch Emile Roux
Le Puy-en-Velay, France
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Clinique de la Côte d'Emeraude
St-Malo, France
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Hopital Charles LeMoyne
Greenfield Park, Quebec, Canada
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Hospices civils de Lyon - Hôpital Edouard Herriot
Lyon, France
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Hôpital Européen Georges Pompidou
Paris, France
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Hôpital Saint Antoine
Paris, France
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Hôpital privé Jean Mermoz
Lyon, France
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Icm Val D'Aurelle
Montpellier, France
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Institut Jean Godinot
Reims, France
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Institut de Cancérologie de l'Ouest -site Paul Papin
Angers, France
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Institut de Cancérologie de l'Ouest -site René Gauducheau
Nantes, France
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The PEI Cancer Treatment Centre Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, Canada
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