An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin As Treatment For Chemotherapy-Naive Patients With Extensive Disease - Small Cell Lung
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare different chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
- Compare the overall survival of patients with chemotherapy-naive extensive stage small cell lung cancer treated with cisplatin and oral topotecan vs cisplatin and etoposide.
- Compare the response rates, response duration, and time to progression in patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
- Compare the patient-perceived disease status and well being in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender, ECOG performance status (0 vs 1 vs 2), lactate dehydrogenase (less than 1.5 times upper limit of normal (ULN) vs 1.5 times ULN or greater), and country. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral topotecan once daily on days 1-5 and cisplatin IV on day 5.
- Arm II: Patients receive cisplatin IV on day 1 and etoposide IV over at least 30 minutes on days 1-3.
Treatment in both arms repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
oral topotecan plus cisplatin IV
oral topotecan once daily on days 1-5 and cisplatin IV on day 5
干预措施: cisplatin (Drug)
oral topotecan plus cisplatin IV
oral topotecan once daily on days 1-5 and cisplatin IV on day 5
干预措施: topotecan hydrochloride (Drug)
Cisplatin IV plus etoposide IV
Cisplatin IV on day 1 and etoposide IV over at least 30 minutes
干预措施: cisplatin (Drug)
Cisplatin IV plus etoposide IV
Cisplatin IV on day 1 and etoposide IV over at least 30 minutes
干预措施: etoposide (Drug)