NCT05179889Enrolling By Invitation2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Disease free survival (DFS)
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm A
Experimental
mFOLFIRINOX
干预措施: mFOLFIRINOX (Drug)
Arm B
Active Comparator
mFOLFOX 6
干预措施: mFOLFOX 6 (Drug)
结局指标
主要结局
Disease free survival (DFS)
时间窗: 3 years after the operation
the time from the date of operation to the date of the first recurrence or the death from any cause
次要结局
- Overall survival (OS)(3 years after the operation)
- Incidence of treatment-related adverse events(3 years after the operation)
研究者
Kyung-ha Lee
Associate professor
Chungnam National University Hospital
研究点 (1)
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