Vinorelbine Plus Gemcitabine (VG) Versus Vinorelbine Plus Carboplatin (VC) in Advanced Non-small Cell Lung Cancer. An Open Randomized Multicenter Phase III Trial From Norwegian Lung Cancer Study Group (NLCG)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 444
- 试验地点
- 4
- 主要终点
- survival
研究概览
简要总结
The purpose of this study is to explore if the combination of vinorelbine and gemcitabine is better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung cancer, in terms of survival, quality of life and need for palliative radiotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-small cell lung cancer stage IIIB or IV
- •Not eligible for radical radiotherapy or surgery
- •WHO performance status 0-2
排除标准
- •Pregnancy
- •Other clinical active cancer disease
- •ALAT/ALP more than 3 times upper normal limit, bilirubin >1.5 upper limit
- •Bowel disease that causes malabsorption
研究组 & 干预措施
A
Day 1: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Gemcitabine infusion 1000 mg/m2 Day 8: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Gemcitabine infusion 1000 mg/m2
All patients will receive a maximum of 3 courses with an interval of 3 weeks
干预措施: Vinorelbine (Drug)
A
Day 1: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Gemcitabine infusion 1000 mg/m2 Day 8: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Gemcitabine infusion 1000 mg/m2
All patients will receive a maximum of 3 courses with an interval of 3 weeks
干预措施: Gemcitabine (Drug)
B
Day 1: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Carboplatin infusion AUC = 5 (Calvert's formula) Day 8: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2
All patients will receive a maximum of 3 courses with an interval of 3 weeks
干预措施: Vinorelbine (Drug)
B
Day 1: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Carboplatin infusion AUC = 5 (Calvert's formula) Day 8: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2
All patients will receive a maximum of 3 courses with an interval of 3 weeks
干预措施: Carboplatin (Drug)
结局指标
主要结局
survival
时间窗: one year
次要结局
- Need for palliative radiotherapy(one year)
- Health related quality of life (HrQoL)(3 months)
- Toxicity(3 months)