NCT00658580已完成3 期
A Phase III Randomized Study Comparing A Chemotherapy With Cisplatin And Etoposide To A Etoposide Regimen Without Cisplatin For Patients With Extensive 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
- 361
- 试验地点
- 4
- 主要终点
- Survival
研究概览
简要总结
The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival in comparison to a regimen containing etoposide and without platinum derivative.
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
- •Histological or cytological diagnosis of small-cell lung cancer
- •Extensive disease (i.e. a disease with distant metastases or that cannot be included in a single irradiation field incorporating primary tumour, mediastinum and supraclavicular lymph node(s))
- •Availability for participating in the detailed follow-up of the protocol
- •Presence of an evaluable or measurable lesion
- •Informed consent
排除标准
- •Prior treatment with chemotherapy, radiotherapy or surgery
- •Performance status < 60 on the Karnofsky scale
- •A history of prior malignant tumor, except non-melanoma skin cancer or in situ carcinoma of the cervix or a cured cancer (defined as a disease-free interval > 5 years)
- •White blood cells < 4000/mm3
- •Platelets < 100000/mm3
- •Serum bilirubin > 1.5 mg/100 ml
- •Serum creatinine > 1.3 mg/100 ml and creatinine clearance <60 ml/min
- •Recent myocardial infarction (less than 3 months prior to date of diagnosis)
- •Congestive cardiac failure or cardiac arrhythmia uncontrolled by medical treatment
- •Uncontrolled infectious disease
- •Serious medical or psychological factors which may prevent adherence to the treatment schedule
研究组 & 干预措施
A
Active Comparator
Every 3 weeks intravenous cisplatin plus etoposide
干预措施: Cisplatin + etoposide (Drug)
B
Experimental
Every 3 weeks intravenous epirubicin plus ifosfamide plus etoposide
干预措施: Epirubicin + ifosfamide + etoposide (Drug)
结局指标
主要结局
Survival
时间窗: Survival will be dated from the day of randomisation until death or last follow up
次要结局
- Response rate(Every 3 cycles of chemotherapy)
- Toxicity(After every cycle of chemotherapy)
研究者
研究点 (4)
Loading locations...
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