NCT01874678已完成不适用
A Study of TS-1 Plus Cisplatin in Patients With Advanced Non-small-cell Lung Cancer
TTY Biopharm5 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- overall response rate
研究概览
简要总结
Objectives:
- Primary Objective:
To bridge the data of efficacy in term of overall response rate of TS-1 plus cisplatin in Taiwanese advanced NSCLC patients from that gained from Japanese population 2. Secondary Objectives:
A. To assess progression free survival B. To assess overall survival C. To bridge the safety profile by assessing the toxicities and tolerability
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for inclusion, each subject must fulfill all of the following criteria:
- •histologically or cytologically confirmed non-small cell bronchogenic carcinoma
- •Stage IIIb or IV disease
- •presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as ≥20 mm with conventional CT/MRI or ≥10 mm with spiral CT scan
- •performance status of ECOG 0, 1
- •age between 20 and 74 years at registration
- •life expectancy of at least 12 weeks
- •ability to take the oral study medication (TS-1)
- •voluntarily signed the written informed consent form.
排除标准
- •other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to the entry of study
- •previously received chemotherapy or therapy with systemic anti-tumor effect
- •significant co-morbid medical conditions, including, but not limited to , heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes
- •fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period and for three months following cessation of treatment
- •Presence of mental disease or psychotic manifestation
- •Participation in another clinical trial with any investigational drug within 30 days prior to entry
- •judged ineligible by physicians for participation in the study due to safety concern.
研究组 & 干预措施
TS-1/Cisplatin
Experimental
single arm
干预措施: TS-1/Cisplatin (Drug)
结局指标
主要结局
overall response rate
时间窗: 2 year
To assess overall response rate
次要结局
- To assess progression free survival To assess overall survival To bridge the safety profile by assessing the toxicities and tolerability(2 year)
研究者
研究点 (5)
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