JPRN-C000000245已完成3 期
Phase III Comparative Clinical Trial of Treatment Schedules for Oral UFT/LV Therapy as Postoperative Adjuvant Chemotherapy for Stage IIB/III Colorectal Cancer
Japanese Foundation for Multidisciplinary Treatment of Cancer0 个研究点目标入组 840 人开始时间: 2005年9月22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
- 840
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 75years-old（—）
- 性别
- All
入选标准
- •1) Histologically confirmed colorectal cancer
- •2) Histological Stage IIB, IIIA, IIIB, IIIC located in colon and rectosigmoid
- •3) Curative resection with D2 or more lymph node dissection
- •4) Resection of histological curability A was performed
- •5) Performance status (ECOG) 0, 1
- •6) No prior chemotherapy and radiotherapy
- •7) Oral intake is possible
- •8) Sufficient organ functions
- •a) WBC >= 3,000/mm3, <12,000/mm3
- •b) Neutrophil >=1,500/mm3
- •c) Hemoglobin >= 9.0g/dL
- •d) Platelet >= 100,000/mm3
- •e) Total bilirubin < 1.5mg/dL
- •f) AST, ALT < 100IU/L
- •g) Serum creatinine < 1.5mg/dL
- •9) Chemotherapy will be started within 6 weeks from operation
- •10) Written informed consent
排除标准
- •1) active synchronous or metachronous malignancy other than carcinoma in situ
- •2) 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
- •3) pregnant or nursing
- •4) severe mental disorders
- •5) not suitable for participating in the study for any other reason
研究者
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