JPRN-UMIN000001367已完成3 期
An Open-Label Randomized Phase III Study of Capecitabine(6 months) versus Capecitabine(12 months) as Adjuvant Chemotherapy for Stage III(Dukes'C) Colon Cancer Patients.
Japanese Foundation for Multidisciplinary Treatment of Cancer0 个研究点目标入组 1,200 人开始时间: 2008年9月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- •1) Histologically confirmed Colorectal adenocarcinoma
- •2) Histological Stage III Colon, Rectosigmoid cancer
- •3) Curative resection with D2 or more lymph node dissection
- •4) Resection of histological curability A was performed
- •5) Performance status(ECOG): 0 or 1
- •6) No prior chemotherapy and radiotherapy
- •7) Oral intake is possible
- •8) Sufficient organ functions
- •WBC >= 3,000/mm3, <12,000/mm3
- •Hemoglobin >= 9.0g/dL
- •Platelet >= 90,000/mm3
- •Serum creatinine <= 1.5xULN
- •Total bilirubin <= 1.5 xULN
- •AST,ALT <= 2.5xULN
- •ALP <= 2.5xULN
- •9) Creatinine clearance >50mL/min
- •10) Chemotherapy will be started within 8 weeks from operation
- •11) Written informed consent
排除标准
- •1) Pregnant or nursing
- •2) Medical history of allergy or hypersensitivity reactions to fluoropyrimidines
- •3) The past of the internal organ transplant
- •4) Serious coexisting illness
- •a; severe pulmonary dysfunction
- •b; ileus or colon dysfunction
- •c; uncontrolled diabetes mellitus
- •d; liver cirrhosis
- •e; uncontrolled hypertension
- •f; history of myocardial infarction, unstable angina within 6 months prior to the registration
- •5) Active synchronous or metachronous malignancy other than carcinoma in situ
- •6) Uncontrollable infectious disease
- •7) Not suitable for participating in the study for any other reason
研究者
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