NCT00622349已完成3 期
A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-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
- 707
- 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 cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC
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 non-small cell lung cancer
- •Advanced (unresectable or functionally inoperable) stage III or stage IV disease
- •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
- •Operable patient with resectable tumour
- •Performance status < 60 on the Karnofsky scale
- •A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
- •Polynuclear cells < 2,000/mm³
- •Platelet cells < 100,000/mm³
- •Serum bilirubin >1.5 mg/100 ml
- •Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 60 ml/min
- •Perception hypoacousia
- •Peripheral neuropathy
- •Recent myocardial infarction (less than 3 months prior to date of diagnosis)
- •Congestive cardiac failure requiring medical therapy or uncontrolled cardiac arrhythmia
- •Uncontrolled infectious disease
- •Serious medical or psychological factors which may prevent adherence to the treatment schedule
研究组 & 干预措施
A
Experimental
干预措施: Cisplatin, Ifosfamide, Gemcitabine (Drug)
B
Active Comparator
干预措施: Ifosfamide, Gemcitabine (Drug)
C
Experimental
干预措施: Cisplatin, docetaxel (Drug)
结局指标
主要结局
Survival
时间窗: Survival will be dated from the first day of registration until death or last follow up
次要结局
- Response rate(Every 3 courses of chemotherapy)
- Toxicity(After each course of chemotherapy)
- Activity of second-line chemotherapy(Every 3 courses of chemotherapy)
研究者
研究点 (4)
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