NCT00148291已完成3 期
Phase III Study of Docetaxel Vs Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer
West Japan Thoracic Oncology Group0 个研究点目标入组 180 人开始时间: 1999年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
研究概览
简要总结
Vinorelbine is currently the standard treatment for elderly patients with advanced non-small cell lung cancer (NSCLC). Docetaxel has also shown promising results against elderly patients in phase II studies. We conducted a randomized phase III trial to evaluate whether docetaxel provided better overall survival than vinorelbine in elderly 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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chemotherapy- and radiotherapy-naïve patients with histologically or cytologically diagnosis of stage IIIB or IV NSCLC and who were ≧ 70 years old with measurable or assessable disease were eligible for this trial. They had to have a life expectancy of at least 3 months. Additional entry criteria were as follows: (a) a performance status (PS) 0 to 2 on the Eastern Cooperative Oncology Group scale; (b) adequate function of bone marrow (leukocyte count ≧ 4,000/μL, absolute neutrophil count ≧ 2,000/μL, hemoglobin concentration ≧ 9.5 g/dL, platelet count ≧ 100,000/μL), kidney (serum creatinine ≦ 1.2 mg/dL), liver (total bilirubin ≦ 1.5 times the institutional upper limits of normal, transaminase of AST and ALT ≦ 2.5 times the institutional upper limits of normal).
排除标准
- •Patients with symptomatic brain metastasis or apparent dementia were ineligible. Patients with active concomitant malignancy, massive pleural effusion or ascites, active infection, severe heart disease, grade 2 or higher ECG abnormality, uncontrolled diabetes mellitus, ileus, pulmonary fibrosis, diarrhea, and a bleeding tendency were excluded.-
研究者
相似试验
已完成
3 期
Phase 3 study of docetaxel vs vinorelbine in elderly patients with advanced non-small cell lung cancerelderly patients with advanced non-small cell lung cancerJPRN-C000000117West Japan Oncology Group180
Unknown
2 期
Maintenance Oral Vinorelbine or Observation After Vinorelbine-Docetaxel First Line Chemotherapy in Advanced Breast CaBreast CancerNCT02144194Cancer Research Group - Collaborative Group, Beirut, Lebanon.65
已完成
2 期
Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant MelanomaMetastatic MelanomaNCT00256282John P. Fruehauf52
终止
2 期
Docetaxel Plus Bevacizumab for Elderly Patients With Stage IV NSCLCNSCLCNCT02179567Hellenic Oncology Research Group26
Unknown
不适用
Observational Study With Metronomic Oral Vinorelbine in Elderly Patients With Locally Advanced / Metastatic Non-small-cell Lung Cancer (NSCLC)Locally Advanced/ Metastatic NSCLCNCT04208854International Group of Endovascular Oncology40