Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer

Study Overview
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Brief Summary
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A multicenter, open labeled randomized, phase II trial comparing mFOLFIRINOX and mFOLFOX6 as adjuvant treatment for high risk stage III (pT4N1/2 or pTanyN2) colon cancer

Detailed Description
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After inclusion and exclusion criteria have been fulfilled and the patient consent has been obtained, the patient will be included and randomized to mFOLFIRINOX or mFOLFOX 6 with a 1:1 ratio. Arm A: mFOLFIRINOX Arm B: mFOLFOX

Official Title
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mFOLFIRINOX Versus mFOLFOX 6 as Adjuvant Treatment for High Risk Stage III (pT4N1/2 or pTanyN2) Colon Cancer: Multicenter, Open Labeled, Randomized, Phase II Study

Conditions
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Colon Cancer Stage III

Intervention / Treatment
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* Drug: mFOLFIRINOX
* Drug: mFOLFOX 6


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 20-70 years with an ECOG ≤ 2 Age of 71-75 years with an ECOG = 0 Pathologically confirmed high-risk stage III colon adenocarcinoma (pT4N1 or pTanyN2) Curative radical resection (successful R0 resection) within 60 days before randomization Adequate organ functions ANC ≥ 2×106 cells/mL Hemoglobin ≥ 9.0 g/dL Platelets ≥ 100×106 cells/mL Alanine aminotransferase/aspartate aminotransferase ≤2.5 × times the upper limit of normal (ULN) Serum total bilirubin ≤ 1.5 ULN Alkaline phosphatase ≤ 2.5 × ULN Serum creatinine ≤1.5 × ULN or creatinine clearance > 50 mL/min (Cockcroft-Gault formula) Able to understand and willing to sign and date written voluntary informed consent form Life expectancy ≥ 5 years Exclusion Criteria: Distant metastasis Middle or lower rectal cancer of need for radiotherapy Postoperative complication of 3 or more grades of Clavien-Dindo classification Underlying disease or postoperative condition which is contraindication for chemotherapy Known hypersensitivity reaction to any study treatment component Familial adenomatosis polyposis or hereditary non-polyposis colorectal cancer Inflammatory bowel disease Previous other malignancy which cannot be curatively treated Pregnancy or breast feeding Any other situation would exclude the patient from study based on the investigator's opinion

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>mFOLFIRINOX | Drug: mFOLFIRINOX<br>* Irinotecan 150 mg/m2 IV day 1, oxaliplatin 85 mg/m2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg/m2 IV day 1, 5-FU 1200 mg/m2/d IV x 2 days (total 2400 mg/m2 over 48 hours) continuous infusion] 12 cycles per 2 weeks mFOLFOX 6 [Oxaliplatin 85 mg/m2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg/m2 IV day 1, 5-FU 400 mg/m2 IV bolus day 1, 5-FU 1200 mg/m2/d IV x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion, 12 cycles per 2 week<br>|
| Active Comparator: Arm B<br>mFOLFOX 6 | Drug: mFOLFOX 6<br>* Oxaliplatin 85 mg/m2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg/m2 IV day 1, 5-FU 400 mg/m2 IV bolus day 1, 5-FU 1200 mg/m2/d IV x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion, 12 cycles per 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival (DFS) | the time from the date of operation to the date of the first recurrence or the death from any cause | 3 years after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | the time from the date of operation to the date of the death from any cause | 3 years after the operation | 
| Incidence of treatment-related adverse events | Toxicity of all grade and more than grade 3 based on CTCAE version 5.0 | 3 years after the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High risk stage III (pT4N1/2 or pTanyN2) colon cancer