JPRN-C000000385已完成3 期
A randomized controlled study comparing S-1 with UFT as postoperative adjuvant Chemotherapy in Rectal Cancer.
Japanese Foundation for Multidisciplinary Treatment of Cancer0 个研究点目标入组 800 人开始时间: 2006年4月1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
- 800
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 rectal adenocarcinoma (exclude Rs)
- •2) Histological Stage IIA, IIB, IIIA, IIIB, IIIC located
- •3) No synchronous colorectal cancer which invade submucosa or deeper
- •4) Curative resection with lymph node dissection
- •5) Resection of histological curability A was performed
- •6) No prior therapy
- •7) Within 42 days after the operation
- •8) Oral intake is possible
- •9) Sufficient organ functions
- •a. WBC >= 3,500/mm3
- •b. Hemoglobin >= 9g/dL
- •c. Platelet >= 100,000/mm3
- •d. Total bilirubin <= 1.2mg/dL
- •e. AST, ALT < 100IU/L
- •f. Serum creatinine <= 1.0mg/dL
- •10) Written informed consent
排除标准
- •1) Anal gland derived cancer of anal canal
- •2) Active synchronous or metachronous malignancy other than carcinoma in situ
- •3) Serious postoperative complications
- •4) Serious coexisting illness
- •a. interstitial pneumonia, pulmonary fibrosis
- •b. intestinal paralysis or obstruction
- •c. uncontrolled diabetes mellitus
- •d. hepatic cirrhosis
- •e. hepatic failure
- •f. renal failure
- •g. uncontrolled hypertension
- •h. history of myocardial infarction, unstable angina within 6 months prior to the registration
- •5) Limitation of use of UFT or TS-1
- •6) Under treatment with flucytosine, phenytoin, or warfarin
- •7) Episode of drug allergy reaching grade 3 or more severe
- •8) Pregnant or nursing
- •9) Severe mental disorders
- •10) Positive HIV
- •11) Not suitable for participating in the study for any other reason
研究者
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