NCT00265694Unknown3 期
A Randomized Phase III Trial of Vinorelbine Versus Gemcitabine and Carboplatin for Elderly Patients With Advanced Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 试验地点
- 2
研究概览
简要总结
- Recently a radomized trial of vinorelbine versus best supportive care in patients at 70 years of age or older demonstrated a definite improvement in overall survival rate and quality of life with chemotherapy.
- The role of combination therapy containing the platinum compound, which is the standard therapy for the young patients is still vague.
- Gemcitabine and carboplatin have favorable toxicity profile.
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 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologically confirmed, advanced(clinical stage IIIB or IV) NSCLC
- •No previous chemotherapy history
- •Age ≥ 65 years
- •ECOG performance status ≤ 2
- •Adequate marrow function (ANC ≥ 2,000/mm3, platelet ≥ 100,000/mm3), renal and liver function (total bilirubin < 2.0 mg/dL, AST/ALT levels < 3 × the upper limit of normal, serum creatinine < 2.0 mg/dL)
- •Patients with informed written consent
排除标准
- •Patients with other major illness(active infection, severe heart disease, concomitant malignancy, etc)
研究者
研究点 (2)
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