NCT00826644已完成3 期
A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- To assess the response Rate of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer
研究概览
简要总结
Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer.
Primary endpoints
- to assess Response Rate
Secondary endpoints
- to assess Overall response duration, Time to progression, Overall survival
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG Performance status 0~2(those with performance status 2 must have been stable with no deterioration over the previous 2 weeks)
- •Histologically or cytologically confirmed small cell lung cancer Patient without chemotherapy and radiotherapy
- •Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site
- •Life expectancy of at least 3 months
- •Provision of written informed consent
排除标准
- •As judged by the investigator, any evidence of severe or uncontrolled systemic disease
- •Serum bilirubin greater than 3 times the upper limit of reference range(ULRR)
- •Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT)greater than 2.5 times ULN if no demonstrable liver metastases (or > 5 times in presence of liver metastases)
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
- •Pregnancy or breast-feeding women(women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
- •Evidence of brain metastasis
研究组 & 干预措施
Belotecan plus Cisplatin
Experimental
干预措施: Belotecan (Drug)
Belotecan plus Cisplatin
Experimental
干预措施: Cisplatin (Drug)
Etoposide plus Cisplatin
Active Comparator
干预措施: Etoposide (Drug)
Etoposide plus Cisplatin
Active Comparator
干预措施: Cisplatin (Drug)
结局指标
主要结局
To assess the response Rate of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer
时间窗: two years
次要结局
- to assess the overall survival(two years)
- To assess the time to progression(two years)
- to assess the overall response duration(two years)
研究者
In-Jae, Oh, MD
Assistant Professor
Chonnam National University Hospital
研究点 (1)
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