NCT00625352Unknown2 期
Prospective Phase II Trial of a Combination of Gemcitabine and UFT as First-Line Treatment in Elderly Patients With Advanced Non-Small Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- overall response rate
研究概览
简要总结
Cares for elderly patients with advanced non-small cell lung cancer(NSCLC) become one of the common clinical practices oncologist are now facing. So, we need to seek adequate regimens for them. Gemcitabine is well known to be one of active third generation agents in terms of both efficacy and tolerability. Gemcitabine alone have been recommended as first line treatment for elderly NSCLC patients, especially in the aspect of tolerability. However, gemcitabine alone is suggested to be suboptimal to control their disease. Therefore, we plan to make an optimal regimen containing gemcitabine for the elderly patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer Stage IIIB/IV
- •No prior chemotherapy
- •Existence of measurable disease. The measurable disease should not have been irradiated
- •Life expectancy of more than 3 months
- •Age ≥ 70 years
- •Performance status (ECOG):1 or 2
- •Adequate bone marrow function (Absolute neutrophil count >1500/mm^3, Platelet count>100000/mm^3, Hemoglobin>9gr/mm^3)
- •Adequate liver (Bilirubin<2 times upper limit of normal and SGOT/SGPT<3 times upper limit of normal) and renal function (creatinine<1.5mg/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
- •Currently/recently taken warfarin, phenprocoumon or phenytoin
- •Hypersensitivity history to any drug
结局指标
主要结局
overall response rate
时间窗: every two cycles
次要结局
- toxicity, response duration, progression free survival, overall survival(according to protocol)
研究者
研究点 (2)
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