JPRN-C000000282已完成1 期
Phase I/II Study of Combination Therapy of Oral Fluorinated Pyrimidine Compound S-1 with Low-dose Cisplatin in Patients with Unresectable and/or Recurrent Advanced Gastric Cancer Step 2: low dose cisplatin given twice a week + S-1
Japanese Foundation for Multidisciplinary Treatment of Cancer0 个研究点目标入组 52 人开始时间: 2005年11月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
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 or cytologically demonstrated unresectable or recurrent gastric cancer
- •2) With measurable or assessable legion(s)
- •3) Without prior anti-tumor therapy. Hormone therapy and/or immunotherapy within two weeks prior to enrollment are eligible. Postoperative adjuvant therapy not containing CDDP within one month prior to enrollment is eligible.
- •4) Adequate bone marrow, hepatic and renal function
- •(1)Hb >= 9.0 g/dl
- •(2)WBC 4,000 - 12,000/mm3
- •(3)neutrophils >= 2,000/mm3
- •(4)platelets >= 100,000/ mm3
- •(5)T-Bil <= 1.5mg/dl
- •(6)GOT, GPT <= 2.5 times of normal upper limits
- •(7)Al-p <= 2 times of normal upper limits
- •(8)BUN <= normal upper limits
- •(9)Cr<= normal upper limits
- •(10)CCr >= 50ml/min
- •5) ECOG performance status (PS) 0 to 1
- •6) Life expectancy longer than 3 months
- •7) Oral intake is possible
- •8) Written informed consent
排除标准
- •1) severe complication(s)
- •2) symptomatic brain metastases
- •3) active double cancers
- •4) women who are currently pregnant, nursing, or plan to become pregnant
- •5) cases where the investigator disapproved of participation
研究者
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