Adjuvant FOLFOXIRI for High-risk Stage III Colon Cancer

  • STATUS
    Recruiting
  • End date
    Mar 15, 2028
  • participants needed
    308
  • sponsor
    Chungnam National University Hospital
Updated on 26 March 2022

Summary

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

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: FOLFOXIRI Arm B: mFOLFOX

Details
Condition Colon Cancer Stage III
Treatment FOLFOXIRI, mFOLFOX 6
Clinical Study IdentifierNCT05179889
SponsorChungnam National University Hospital
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

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
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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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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