Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer
Primary Purpose
Colon Cancer Stage III
Status
Enrolling by invitation
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
mFOLFIRINOX
mFOLFOX 6
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer Stage III focused on measuring High risk stage III (pT4N1/2 or pTanyN2) colon cancer
Eligibility Criteria
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
Sites / Locations
- Chungnam National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A
Arm B
Arm Description
mFOLFIRINOX
mFOLFOX 6
Outcomes
Primary Outcome Measures
Disease free survival (DFS)
the time from the date of operation to the date of the first recurrence or the death from any cause
Secondary Outcome Measures
Overall survival (OS)
the time from the date of operation to the date of the death from any cause
Incidence of treatment-related adverse events
Toxicity of all grade and more than grade 3 based on CTCAE version 5.0
Full Information
NCT ID
NCT05179889
First Posted
December 17, 2021
Last Updated
August 28, 2023
Sponsor
Chungnam National University Hospital
Collaborators
Boryung Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05179889
Brief Title
Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 6, 2021 (Actual)
Primary Completion Date
March 15, 2025 (Anticipated)
Study Completion Date
March 15, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chungnam National University Hospital
Collaborators
Boryung Pharmaceutical Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer Stage III
Keywords
High risk stage III (pT4N1/2 or pTanyN2) colon cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
308 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
mFOLFIRINOX
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
mFOLFOX 6
Intervention Type
Drug
Intervention Name(s)
mFOLFIRINOX
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
mFOLFOX 6
Intervention Description
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
Primary Outcome Measure Information:
Title
Disease free survival (DFS)
Description
the time from the date of operation to the date of the first recurrence or the death from any cause
Time Frame
3 years after the operation
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
the time from the date of operation to the date of the death from any cause
Time Frame
3 years after the operation
Title
Incidence of treatment-related adverse events
Description
Toxicity of all grade and more than grade 3 based on CTCAE version 5.0
Time Frame
3 years after the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Ha Lee
Organizational Affiliation
Chungnam National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
34112
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer
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