NCT00441922已完成3 期
A Multicenter Randomized Phase II Study of Docetaxel Versus Vinorelbine as First-Line Treatment in Elderly Patients With Advanced 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 166 人开始时间: 2003年1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
- 166
- 试验地点
- 10
- 主要终点
- Overall survival between the two treatment arms
研究概览
简要总结
This trial will compare the efficacy of docetaxel versus vinorelbine as first-line treatment in elderly patients with advanced NSCLC.
详细描述
Docetaxel and vinorelbine are well known active agents in the treatment of NSCLC. The standard treatment of elderly patients with advanced NSCLC is monotherapy with a third generation agent. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.
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
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer
- •Stage IIIB/IV
- •No prior chemotherapy
- •Existence of two-dimensional measurable disease. The measurable disease should not have been irradiated
- •Life expectancy of more than 3 months
- •Age ≥ 65 years
- •Performance status (WHO) ≤ 3
- •Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, Hemoglobin > 9 gr/mm^3)
- •Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal), and renal function (creatinine < 2 mg/dl)
- •Informed consent
排除标准
- •Psychiatric illness or social situation that would preclude study compliance.
- •Other concurrent uncontrolled illness
- •Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •No absence or irradiated and stable central nervous system metastatic disease.
- •No presence of a reliable care giver
- •Other concurrent investigational agents
研究组 & 干预措施
1
Experimental
D
干预措施: Docetaxel (Drug)
2
Experimental
V
干预措施: Vinorelbine (Drug)
结局指标
主要结局
Overall survival between the two treatment arms
时间窗: 1 year
次要结局
- Time to disease progression(1 year)
- Toxicity profile(During the time of chemotherapy)
研究者
研究点 (10)
Loading locations...
相似试验
终止
2 期
Docetaxel/Carboplatin Versus Docetaxel/Caelyx in Pretreated Patients With Ovarian CarcinomaOvarian CancerNCT00758732Hellenic Oncology Research Group34
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 Alone or in Combination With Vaccine to Treat Breast CancerBreast CancerNCT00179309National Cancer Institute (NCI)48
已完成
3 期
Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast CancerBreast CancerNCT00429871Hellenic Oncology Research Group272
Unknown
2 期
Trial of Adjuvant Chemotherapy for High Risk Gastric Cancer PatientsStomach CancerNCT01618474Tianjin Medical University Cancer Institute and Hospital100