JPRN-UMIN000001527已完成3 期
Randomized Phase III Trial Comparing surgery-alone to UFT+PSK in Stage II Rectal Cancer
Japanese Foundation for Multidisciplinary Treatment of Cancer0 个研究点目标入组 540 人开始时间: 2009年1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
- 540
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)Stage II,Histologically confirmed adenocarcinoma of the rectum.
- •2)Patients with resection of a rectal cancer with D2 or more lymph node dissection.
- •4)Performance status:0-2
- •5)Patients without receiving chemotherapy, radiation exposure, rectum resection (remove the local operation), and the excision of the pelvis lymph node ,including the treatment for the other carcinoma.
- •6)Patients who have satisfied the following the latest clinical test values in two weeks or after operation and within two weeks before the registration.
- •1.WBC:>= 3,000/mm3, <12,000/mm3
- •2.Neutrophile:>= 1,500/mm3
- •3.Hemoglobin:>= 9.0g/dL
- •4.Platelet:>= 100,000/mm3
- •5.Total bilirubin:< 1.5 mg/dL
- •6.AST,ALT:<100IU/L
- •7.Serum creatinine:<1.5mg/dL
- •7)Patient with starting the chemotherapy within 8 weeks after operation.
- •8)Patients who have given consent to participate in this clinical study by himself/herself.
排除标准
- •1)Ingestion impossibility or digestive organs stricture.
- •2)Serious coexisting illness.
- •3)Primary tumor in Proctos(P) or External skin (E).
- •4)Active synchronous or metachronous malignancy carcinoma in situ.
- •5)Pregnant or nursing.
- •6)Not suitable for participating in the study for any other reason.
研究者
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