NCT00168896Unknown2 期
A Randomised Phase II/III Study to Compare the Combination of Carboplatin Plus Irinotecan Vs. the Combination of Carboplatin Plus Etoposide for SCLC in Extensive Disease Stage
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 286
- 试验地点
- 2
- 主要终点
- Primary Endpoint:
研究概览
简要总结
Comparison of two combination chemotherapies in the treatment of patients with SLCL
详细描述
Comparison of two combination chemotherapies in the treatment of patients with SLCL
The combination chemotherapies for this study are Carboplatin plus Irinotecan versus Carboplatin plus Etoposide.
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
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cytological or histological proven SCLC Stage I or II at 1st diagnosis
- •no prior chemotherapy
- •measurable tumor disease
- •karnofsky performance 70
排除标准
- •second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri)
- •chronic diarrhea, obstructive bowel syndrome
结局指标
主要结局
Primary Endpoint:
Documentation of the remission rate ( Phase II)
Determination of progress free time (Phase III)
次要结局
- Secondary Endpoint:
- Documentation of progress free time (Phase II)
- Documentation of objective remission rate ( Phase III)
- Documentation of 1-year survival rate
- Documentation of safety of the drug combination
研究者
研究点 (2)
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