mFOLFIRINOX versus mFOLFOX 6 as adjuvant treatment for high risk stage III colon cancer: open label, multicenter, randomized, phase II stud

Chungnam National University Hospital0 个研究点目标入组 308 人开始时间: 待定最近更新: 2022年6月27日

试验速览

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•? Age of 20-70 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less, or age of 71–75 years with an ECOG performance status of 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

•? 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 (If a female participant is likely to be pregnant, a pregnancy test is conducted prior to the beginning of the study to verify the availability of treatment before registration. Pregnancy tests are tracked every month from the start of treatment to the end. Both male and female participants shall be required to have contraception until at least six months after the end of treatment, and if they plan to get pregnant afterwards, they shall consult with their doctor. )
•? Any other situation would exclude the patient from study based on the investigator’s opinion

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