NCT00430651已完成3 期
Multicenter Randomized Phase III Study Comparing Docetaxel With Carboplatin Versus Docetaxel Single Agent as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (NSCLC).
Hellenic Oncology Research Group10 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2004年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 10
- 主要终点
- Comparison of the overall survival between the two treatment groups
研究概览
简要总结
This trial will compare the effectiveness of Docetaxel with or without Carboplatin as second line chemotherapy in patients with Non-Small Cell Lung Cancer, who have not been treated previously with Docetaxel.
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
- •Histologically or cytologically confirmed NSCLC.
- •ECOG Performance Status 0-
- •No previous treatment with Docetaxel.
- •Measurable Disease.
- •Brain metastases that have been treated with radiotherapy should be stable and asymptomatic.
- •Adequate liver kidney and bone marrow function.
- •Patients must be able to understand the nature of this study and give written informed consent.
排除标准
- •Active cardiac disease: unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure > class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- •Women who are pregnant or lactating.
- •Unknown HIV, chronic hepatitis B or chronic hepatitis C infections.
- •Serious neurologic or psychiatric disease.
- •Second primary malignancy within the past 5 years, except nonmelanomas skin cancer or in situ carcinoma of the cervix.
- •Active uncontrolled infection.
研究组 & 干预措施
1
Experimental
Docetaxel + Carboplatin
干预措施: Docetaxel (Drug)
1
Experimental
Docetaxel + Carboplatin
干预措施: Carboplatin (Drug)
2
Experimental
Docetaxel
干预措施: Docetaxel (Drug)
结局指标
主要结局
Comparison of the overall survival between the two treatment groups
时间窗: 1 year
次要结局
- Comparison of the objective response rates between the two treatment groups(Objective responses confirmed by CT or MRI (on 3rd and 6th cycle))
- Evaluation and comparison of the toxicity between the two treatment groups(Toxicity assessment on each chemotherapy cycle)
- Measurement and comparison of the health-related quality of life of patients on both treatment groups(Assessment every two cycles)
研究者
研究点 (10)
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