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IRinotecan and Oxaliplatin for Colon Cancer in Adjuvant Setting (IROCAS)

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ClinicalTrials.gov Identifier: NCT02967289
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
Canadian Cancer Trials Group
Information provided by (Responsible Party):
UNICANCER

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colon Cancer (High-risk Stage III; pT4N1 or pT1 to 4 N2) Drug: Irinotecan Drug: Folfox Protocol Phase 3

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). 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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for High-risk Stage III Colon Cancer in Adjuvant Setting
Actual Study Start Date : March 27, 2017
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
mFOLFIRINOX Folfox Protocol + Irinotecan
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
Other Name: Campto

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
Other Name: acid folinic + oxaliplatine + 5FU

Active Comparator: Arm B
mFOLFOX 6 Folfox Protocol
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
Other Name: acid folinic + oxaliplatine + 5FU




Primary Outcome Measures :
  1. Disease Free Survival (DFS) [ Time Frame: 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 :
  1. Disease Free Survival [ Time Frame: 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.

  2. Overall Survival [ Time Frame: 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

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




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Ages Eligible for Study:   18 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Patient ≥18 years and <71 years
  • 2. Patient with ECOG ≤1
  • 3. Pathologically confirmed high-risk stage III colon adenocarcinoma, restricted to pT4N1 or pT1-4N2 tumor
  • 4. Curative R0 surgical resection within 42 days before randomization
  • 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) Carcinoembryogenic antigen (CEA) ≤10 ng/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

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: QT/QTc ≥450 msec, for women: QT/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. Known DPD deficiency or UGT1A1 homozygous 7/7
  • 12. Patients already included in another therapeutic trial involving an experimental drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967289


Contacts
Contact: Beata JUZYNA 0033.1.71.93.63.66 b-juzyna@unicancer.fr
Contact: Veronica PEZZELLZ v-pezzella@unicancer.fr

Locations
Canada, Prince Edward Island
The PEI Cancer Treatment Centre Queen Elizabeth Hospital Active, not recruiting
Charlottetown, Prince Edward Island, Canada
Canada, Quebec
Hopital Charles LeMoyne Active, not recruiting
Greenfield Park, Quebec, Canada
Centre hospitalier de l'Université de Montréal Active, not recruiting
Montréal, Quebec, Canada
Canada, Saskatchewan
Allan Blair Cancer Centre Active, not recruiting
Regina, Saskatchewan, Canada
France
Institut de Cancérologie de l'Ouest -site Paul Papin Recruiting
Angers, France
Contact: Sandrine HIRET, MD         
CHD de Vendée Active, not recruiting
La Roche-sur-Yon, France
Ch Emile Roux Recruiting
Le Puy-en-Velay, France
Contact: Kheir Eddine BENNMAMMAR         
Hospices civils de Lyon - Hôpital Edouard Herriot Active, not recruiting
Lyon, France
Hôpital privé Jean Mermoz Recruiting
Lyon, France
Contact: Pascal ARTRU, MD         
Icm Val D'Aurelle Recruiting
Montpellier, France
Contact: Thibault MAZARD         
Institut de Cancérologie de l'Ouest -site René Gauducheau Recruiting
Nantes, France
Contact: Sandrine HIRET         
Hôpital Européen Georges Pompidou Recruiting
Paris, France
Contact: Julien TAIEB, MD         
Hôpital Saint Antoine Active, not recruiting
Paris, France
Centre Hospitalier Annecy Genevois Active, not recruiting
Pringy, France
Institut Jean Godinot Recruiting
Reims, France
Contact: ELISE DESOT         
CHP Saint Grégoire Recruiting
Saint Gregoire, France
Contact: Laurent MIGLIANICO, MD         
Clinique de la Côte d'Emeraude Active, not recruiting
Saint-Malo, France
Sponsors and Collaborators
UNICANCER
Canadian Cancer Trials Group
Investigators
Study Chair: Jaafar BENNOUNA, Professor ICO René Gauducheau, Nantes - Angers
Study Chair: Julien TAIEB, Professor Hôpital Européen Georges-Pompidou, PARIS
Study Chair: Thierry ANDRE, Professor AP-HP Hôpital Saint-Antoine, PARIS

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT02967289     History of Changes
Other Study ID Numbers: UC-0110/1609_PRODIGE52/UCGI29
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by UNICANCER:
colon
cancer
stage 3
high-risk
mFolfirinox
mFolfox6
adjuvant

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Oxaliplatin
Irinotecan
Camptothecin
Fluorouracil
Leucovorin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antidotes
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antimetabolites