A Multicenter Randomized Phase III Study of the Docetaxel and Gemcitabine Combination Versus Monotherapy With Gemcitabine as First-line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 106
- 试验地点
- 9
- 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 the docetaxel and gemcitabine combination versus monotherapy with gemcitabine as first-line treatment in elderly patients with advanced NSCLC
详细描述
Docetaxel and gemcitabine 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. However, there are only few randomized trials evaluating a two drug combination specifically addressed to elderly patients. 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
- 70 Years 至 85 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
- •Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated.
- •Absence or irradiated and stable central nervous system metastatic disease
- •Life expectancy of more than 3 months
- •Age ≥ 70 years.
- •Performance status (WHO) < 3
- •Patients "non-frail" according to comprehensive geriatric assessment
- •Adequate bone marrow function (Absolute neutrophil count > 1000/mm^3, Platelet count > 100000/mm^3, Hemoglobin > 9gr/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 < 2mg/dl).
- •Adequate cardiac function (LVEF > 50%).
- •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 presence of a reliable care giver
- •Other concurrent investigational agents.
研究组 & 干预措施
1
DG
干预措施: Docetaxel (Drug)
1
DG
干预措施: Gemcitabine (Drug)
2
G
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall survival between the two treatment arms
时间窗: Probability of 1 year survival (%)
次要结局
- Overall response rate(Objective responses confirmed by CT or MRI (on 3rd and 6th cycle))
- Time to disease progression(1 year)
- Quality of life assessment(Assessment every two cycles)
- Toxicity profile(Assessment every two cycles)