A Randomized Trial of Irinotecan, Leucovorin, 5-FU (ILF) Versus ILF Plus Cisplatin (PILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Objective response rate
研究概览
简要总结
To compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.
详细描述
Irinotecan, in combination with 5-FU or cisplatin, clearly demonstrated efficacy against gastric cancer. A previous randomized study of ILF regimen versus IP in patients with AGC showed that the ILF produced an overall response rate of 42% and a median survival of 10.7 months, which were significantly better than the results with IP regimen [Pozzo C, et al. Ann Oncol 2004]. However, since cisplatin is still considered one of the key drugs for the treatment of gastric cancer, a combination of these four drugs (irinotecan, leucovorin, FU and cisplatin) seemed to be a promising strategy for advanced AGC. We desinged this randomized phase II study to compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.
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 proven gastric adenocarcinoma
- •Advanced, metastatic or recurrent
- •ECOG performance status 0 to 2
- •No prior chemotherapy
- •Measurable or evaluable indicator lesion(s)
- •Normal marrow, hepatic and renal functions
- •Provision of written informed consent
排除标准
- •Active infection, bleeding or severe comorbidities
- •Pregnant or breastfed women
- •Active CNS metastasis
结局指标
主要结局
Objective response rate
Safety
次要结局
- Progression-free survival
- Overall survival
- Quality of life