NCT00320359已完成3 期
An Open-Label, Multicentre, Randomised, Phase III Study Comparing Topotecan/Cisplatin and Topotecan/Etoposide Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-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
- 700
- 试验地点
- 1
- 主要终点
- Median overall survival time of participants
研究概览
简要总结
Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st line Small Cell Lung Cancer
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
- •Evaluable extensive small cell lung cancer, extensive disease.
- •Eastern Cooperative Oncology Group (ECOG) performance status <
- •Life expectancy > 3 months.
- •Fit to receive any of the treatments.
- •No prior chemotherapy.
- •Written informed consent.
排除标准
- •Extensive disease treatable with radiotherapy.
- •Past or current history of other malignant disease.
- •Prior chemotherapy.
- •Pregnancy, lactating or lack of effective contraception.
- •Concurrent severe medical problems other than small cell lung cancer.
- •Patients with central nervous system metastases receiving more than 12 mg /day dexamethasone or equivalent to control symptoms.
研究组 & 干预措施
Arm A
Active Comparator
Cisplatin 75 mg/m2 i.v., day 1, Etoposide 100 mg/m2 i.v., days 1-3
干预措施: Intravenous etoposide/cisplatin (Drug)
Arm B
Experimental
Topotecan 1 mg/ m2, i.v., days 1-5 Cisplatin 75 mg/m2 i.v., days 5
干预措施: Intravenous topotecan/cisplatin (Drug)
结局指标
主要结局
Median overall survival time of participants
时间窗: Up to 1 year after randomization of the last patient
次要结局
- Mean change from Baseline in Creatinine and Total bilirubin(Baseline and up to 18 weeks)
- Number of participants with one year survival rate of the participants(Up to 1 year after randomization of the last patient)
- Median time to event (progressive disease or death) of participants(Up to 1 year after randomization of the last patient)
- Median time to response to chemotherapy(Up to 1 year after randomization of the last patient)
- Number of participants with objective response(Up to 1 year after randomization of the last patient)
- Mean lung cancer symptom score (LCSS)(Up to 18 weeks)
- Mean change from Baseline in red blood cells (RBCs)(Baseline and up to 18 weeks)
- Mean change from Baseline in Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase and Lactate dehydrogenase (LDH)(Baseline and up to 18 weeks)
- Mean change from Baseline in Blood urea nitrogen (BUN), Potassium, Sodium and urea(Baseline and up to 18 weeks)
- Mean change from Baseline in Body surface area(Baseline and up to 18 weeks)
- Median time of disease progression(up to 1 year after randomization of the last patient)
- Median response duration(Up to 1 year after randomization of the last patient)
- Mean change from Baseline in Creatinine clearance
- Number of participants with abnormal urinalysis results
- Mean change from Baseline in weight(Baseline and up to 18 weeks)
- Mean eastern cooperative oncology group (ECOG) score(Up to 18 weeks)
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)(Up to 1 year after randomization of the last patient)
- Mean change from Baseline in hemoglobin value(Baseline and up to 18 weeks)
- Mean change from Baseline in leukocytes, neutrophils and platelets count(Baseline and up to 18 weeks)
- Mean change from Baseline in total protein(Baseline and up to 18 weeks)
研究者
研究点 (1)
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