NCT01405586进行中（未招募）3 期
Randomized Phase III Study of the Addition of Cisplatin in Combination With Gemcitabine as First-line Therapy for Elderly Patients With Advanced Non Small Cell Lung Cancer.
National Cancer Institute, Naples49 个研究点 分布在 1 个国家目标入组 299 人开始时间: 2011年3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
- 进行中（未招募）
- 发起方
- 入组人数
- 299
- 试验地点
- 49
- 主要终点
- overall survival
研究概览
简要总结
The purpose of this study is to evaluate the addition of cisplatin to first-line chemotherapy with gemcitabine in elderly patients with non small cell lung cancer in terms of overall survival.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytological or histological diagnosis of non small-cell lung cancer (NSCLC)
- •Stage III B or Stage IV disease
- •Age > or = 70 years
- •ECOG Performance status 0 or 1
- •Patient at first diagnosis or with recurrence after primary surgery
- •At least one target or non-target lesion according to RECIST criteria
- •Life expectancy of at least 3 months
- •Neutrophils > 1500/mm3, platelets > 100,000/mm3, hemoglobin > 10g/dl
- •Creatinine < 1.5 x the upper normal limit
- •AST and ALT < 2.5 x the upper normal limits (< 5 x the upper normal limit in the presence of hepatic metastasis)
- •Bilirubin < 1.5 x the upper normal limit
- •Signed informed consent
排除标准
- •Previous chemotherapy for advanced disease
- •History of malignant neoplasm within the previous 5 years (not including non-melanoma skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
- •Symptomatic cerebral or spinal cord metastasis
- •Myocardial infarct within the last 12 months
- •Systemic disease not controlled with treatment (active infection, cardiovascular, hepatic, renal or metabolic) that would not, in the opinion of the investigator, permit the patient to undergo chemotherapy.
- •Known or suspected hypersensitivity to any of the drugs used in the study
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or give informed consent
研究组 & 干预措施
gemcitabine
Active Comparator
干预措施: Gemcitabine (Drug)
gemcitabine + cisplatin
Experimental
干预措施: Gemcitabine (Drug)
gemcitabine + cisplatin
Experimental
干预措施: Cisplatin (Drug)
结局指标
主要结局
overall survival
时间窗: one year
次要结局
- progression free survival(every 9 weeks)
- quality of life(baseline and 8, 21, 29, and 42 days after therapy initiated)
- objective response(after 9 and 18 weeks of therapy)
- worst grade toxicity per patient(at end of each 3 week cycle of chemotherapy)
研究者
研究点 (49)
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