NCT00132665已完成3 期
Randomized Controlled Trial to Evaluate Standard Thoracic Radiotherapy With or Without Concurrent Daily Low-dose Carboplatine in Elderly Patients With Locally Advanced Non-small Cell Lung Cancer (JCOG0301, NCSLC-Elderly-CBDCA-RT Phase III)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 74
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to evaluate whether radiotherapy with carboplatin will result in longer survival than radiotherapy alone in elderly patients with unresectable stage III NSCLC.
详细描述
The purpose of this study is to evaluate whether radiotherapy with carboplatin will result in longer survival than radiotherapy alone in elderly patients with unresectable stage III 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
- 71 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically and/or cytologically proven NSCLC
- •Unresectable disease
- •Stage IIIA except T3N1M0 and IIIB which does not have disease extended to any contralateral hilar nodes, atelectasis of the entire lung or malignant pleural effusions
- •A required radiation field of less than one half of one lung
- •Measurable disease
- •No previous chemotherapy or radiotherapy
- •Age >= 71
- •Unable to receive cisplatin-based combination chemotherapy
- •ECOG performance status (PS) of 0-2
- •Adequate bone marrow, lung, hepatic, and renal function
- •Written informed consent
排除标准
- •Active infection, diarrhea, ileus, uncontrolled diabetes, myocardial infarction within three months, or severe other comorbidity
- •Synchronous cancer or metachronous (within 5 years) malignancy
- •Interstitial pneumonia or active lung fibrosis on chest X-ray
- •Severe chronic obstructive pulmonary disease, chronic bronchitis, or bronchial asthma
- •Pleural or pericardial effusion
- •A history of severe hypersensitivity
- •Mental disorder
- •Judging of inappropriate condition for this study by physician
结局指标
主要结局
Overall survival
时间窗: During the study conduct
次要结局
- Response rate(During the study conduct)
- Adverse events(During the study conduct)
- Progression-free survival(During the study conduct)
- Pattern of progression/relapse(During the study conduct)
研究者
研究点 (74)
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