JPRN-C000000104已完成2 期
A randomized phase II (/III) study of TXT/TS-1 (DS) combination vs CDDP/5-FU therapy (FUP) in metastatic gastric cancer - A randomized phase II study of TXT/TS-1 (DS) vs CDDP/5-FU (FUP) in metastatic gastric cancer
Hiroshima Cancer Therapy Development Organization (HiCTDO)0 个研究点目标入组 130 人开始时间: 2005年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
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
- 未提供
排除标准
- •(1)Accompanied serious diseases (2)Prior adjuvant chemotherapy including a taxane, TS-1, CDDP and 5-FU (3)Oral uptake disturbance (4)A past history of drug allergy (5)A past history of allergic reaction to polysorbate 80 (6)Symptomatic pleural effusion or ascites (7)Symptomatic infectious disease (8)Watery diarrhea (9)Ileus and obstructive bowel disease (10)Pulmonary fibrosis, interstitial pneumonia, symptomatic bleeding tendency, and Hemorrhage/bleeding>=grade 3 (NCI- CTC) (11)Peripheral neuropathy>=grade 2 (12)Edema>=grade 2 (13)Concomitant therapy with flucytocine (14)Active secondary cancer (15)Uncontrollable diabetes (16)Congestive heart failure, symptomatic ischemic heart disease, poorly controlled arrhythmia, A-V block>=grade 2, myocardial infarction cooured within 12 months (17)Symptomatic psychological disease (18)Pregnancy or breast feeding (19)Decision as ineligible by principal investigator
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