Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine as First Line Treatment in Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC). A Prospective , Multicenter, Randomized, Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 419
- 试验地点
- 9
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to evaluate whether the gemcitabine/vinorelbine combination versus the gemcitabine/docetaxel combination as first line treatment, offers a survival advantage in patients with locally advanced/metastatic NSCLC.
详细描述
Cisplatin-based chemotherapy represented the backbone of treatment of advanced NSCLC. However, several trials comparing platinum versus non-platinum based chemotherapy regimens failed to demonstrate a statistically significant difference in terms of time to tumor progression or survival. Newer agents such as gemcitabine, docetaxel and vinorelbine have shown significant activity in the treatment of NSCLC. Gemcitabine/vinorelbine combination as first line treatment has demonstrated a response rate (RR) of 18-43% and a median overall survival (OS) of 9.8-13 months. Similarly, the gemcitabine/docetaxel combination has shown a RR 32-35% and a median OS of 9-12 months. Given their proven efficacy, the combination of these two doublets, would be interesting.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC
- •No previous therapy for advanced/metastatic NSCLC is allowed
- •Age > 18 years
- •Bidimensionally measurable disease
- •Performance status (WHO) 0-2
- •Adequate liver (serum bilirubin < 1.5 times the upper normal limit (UNL); AST and ALT < 2.5 times the UNL in the absence of demonstrable liver metastases, or < 5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine < 1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
- •Previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields
- •Life expectancy of more than 3 months
- •Patient able to take oral medication
- •At least 4 weeks since prior radiotherapy
- •Written informed consent
排除标准
- •Active infection
- •History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- •Malnutrition (loss of ≥ 20% of the original body weight)
- •Performance status: 3-4
- •Sensor or motor neuropathy > grade I
- •Second primary malignancy, except for non-melanoma skin cancer
- •Psychiatric illness or social situation that would preclude study compliance
- •Pregnant or lactating women
- •Known, symptomatic central nervous system metastases
研究组 & 干预措施
1
VG
干预措施: Vinorelbine (Drug)
1
VG
干预措施: Gemcitabine (Drug)
2
DG
干预措施: Docetaxel (Drug)
2
DG
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall survival
时间窗: 1 year
次要结局
- Response rate(Objective responses confirmed by CT or MRI (on 3rd and 6th cycle))
- Time to tumor progression(1 year)
- Toxicity(Toxicity assessment on each chemotherapy cycle)
- Quality of life(Assessment every two cycles)