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

  • STATUS
    Recruiting
  • End date
    Jun 19, 2027
  • participants needed
    792
  • sponsor
    UNICANCER
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Updated on 4 October 2022
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Summary

The trial is a phase III, multicenter, open-labeled randomized trial comparing the association 5-fluorouracil (5-FU), folinic acid, irinotecan and oxaliplatin (mFOLFIRINOX) versus oxaliplatin, folinic acid, 5-FU (mFOLFOX 6) chemotherapy protocols in patients with high-risk stage III colon cancer in the adjuvant setting.

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

Details
Condition Colon Cancer (High-risk Stage III: pT4N1 or pT1 to 4 N2)
Treatment Irinotecan, Folfox Protocol
Clinical Study IdentifierNCT02967289
SponsorUNICANCER
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patient ≥18 years and < 75 years
Patient ≥18 years and <71 years must have an ECOG ≤1 - Patients ≥71 years and < 75 years must have an ECOG = 0
Pathologically confirmed high-risk stage III colon adenocarcinoma, restricted to pT4N1 or pT1-4N2 tumor
Curative R0 surgical resection
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
Start of study drug treatment has to be performed less than 56 days after surgery
No prior chemotherapy
No prior abdominal or pelvic irradiation
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) ≤10ng/mL after surgery (during screening period)
Adequate contraception if applicable
Patient able and willing to comply with study procedures as per protocol
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
Public or private health insurance coverage
Life expectancy of > or = at 5 years
Uracilemia < 16 ng/ml (only for french centers)

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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