PER-025-05已完成未知
OPEN STUDY, MULTICENTER, RANDOMIZED, PHASE 3, OF S-1 IN COMBINATION WITH CISPLATINE COMPARED AGAINST 5-FU IN COMBINATION WITH CISPLATINO, IN PATIENTS WITH ADVANCED GASTRIC CANCER NOT TREATED PREVIOUSLY WITH CHEMOTHERAPY FOR ADVANCED DISEASE
TAIHO PHARMA USA INC.,0 个研究点目标入组 35 人开始时间: 2005年6月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 35
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
- 0 至 0（—）
入选标准
- •1. You have granted written consent.
- •2. Has metastatic or locally advanced gastric cancer (Stage IV) histologically confirmed, not resectable.
- •3. Has a measurable or measurable but not measurable disease.
- •4. No previous palliative chemotherapy is allowed.
- •5. You can take medications orally.
- •6. You are> 18 years old.
- •7. At least 3 weeks of previous major surgery occurred.
- •8. At least 4 weeks of previous radiotherapy were passed.
- •9. Has an activity status 0 to 1 according to ECOG.
- •10. It has an adequate organic function.
- •11. Is willing and able to comply with scheduled visits, treatment plans, laboratory analyzes and other study procedures
排除标准
- •1. Patients who have had treatment with any of the following: a) Any prior palliative chemotherapy or any prior therapy for malignancy. b) Coadjuvant or neoadjuvant therapy within the last 12 months. c = Concurrent treatment with an anticancer agent in research. d = Previous cisplatin as neo-adjuvant chemotherapy and / or adjuvant with cumulative doses> 300 mg / m2. e)> 25% of irradiated medullary bone. f) Concurrent treatment with an agent under investigation or within 30 days of randomization. g) Current enrollment in another clinical study.
- •2. Has a serious illness.
- •3. Patient is receiving concomitant treatment with drugs that interact with S-1.
- •4. Patient is receiving concomitant treatment with drugs that interact with 5-FU.
- •5. Patient is receiving concomitant treatment with drugs that interact with cisplatin.
- •6. Patient is is a woman and is pregnant or breastfeeding.
- •7. Has a known hypersensitivity to 5-FU or cisplatin.
- •8. Patients with reproductive potential who refuse to use adequate contraception
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