IRinotecan and Oxaliplatin for Colon Cancer in Adjuvant Setting
- Conditions
- Colon Cancer (High-risk Stage III: pT4N1 or pT1 to 4 N2)
- Interventions
- Drug: Folfox Protocol
- Registration Number
- NCT02967289
- Lead Sponsor
- UNICANCER
- Brief 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.
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 792
Not provided
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Irinotecan mFOLFIRINOX Folfox Protocol + Irinotecan Arm A Folfox Protocol mFOLFIRINOX Folfox Protocol + Irinotecan Arm B Folfox Protocol mFOLFOX 6 Folfox Protocol
- Primary Outcome Measures
Name Time Method Disease Free Survival (DFS) 3 YEARS after inclusion 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.
- Secondary Outcome Measures
Name Time Method Disease Free Survival 2 YEARS after inclusion 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.Overall Survival 5 YEARS after inclusion Overall Survival (OS) is defined as the time from the date of randomization to the date of documented death from any cause
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 2 YEARS after inclusion 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.
Trial Locations
- Locations (17)
Hôpital Saint Antoine
🇫🇷Paris, France
The PEI Cancer Treatment Centre Queen Elizabeth Hospital
🇨🇦Charlottetown, Prince Edward Island, Canada
Centre hospitalier de l'Université de Montréal
🇨🇦Montréal, Quebec, Canada
Hopital Charles LeMoyne
🇨🇦Greenfield Park, Quebec, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Institut de Cancérologie de l'Ouest -site Paul Papin
🇫🇷Angers, France
Ch Emile Roux
🇫🇷Le Puy-en-Velay, France
CHD de Vendée
🇫🇷La Roche-sur-Yon, France
Hospices civils de Lyon - Hôpital Edouard Herriot
🇫🇷Lyon, France
Hôpital privé Jean Mermoz
🇫🇷Lyon, France
Icm Val D'Aurelle
🇫🇷Montpellier, France
Institut de Cancérologie de l'Ouest -site René Gauducheau
🇫🇷Nantes, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Centre Hospitalier Annecy Genevois
🇫🇷Pringy, France
Institut Jean Godinot
🇫🇷Reims, France
CHP Saint Grégoire
🇫🇷Saint Gregoire, France
Clinique de la Côte d'Emeraude
🇫🇷Saint-Malo, France