Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 46
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.
PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare the overall survival of patients with unresectable metastatic pancreatic cancer treated with fluorouracil, leucovorin calcium, and cisplatin followed by gemcitabine hydrochloride vs gemcitabine hydrochloride followed by fluorouracil, leucovorin calcium, and cisplatin.
Secondary
- Compare progression-free survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the percentage of these patients needing second-line therapy.
- Compare the duration of hospitalization of patients treated with these regimens.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LV5FU2 simplifié + cisplatine puis gemcitabine si progression
LV5FU2 simplifié + cisplatine puis gemcitabine si progression
干预措施: cisplatin (Drug)
LV5FU2 simplifié + cisplatine puis gemcitabine si progression
LV5FU2 simplifié + cisplatine puis gemcitabine si progression
干预措施: fluorouracil (Drug)
LV5FU2 simplifié + cisplatine puis gemcitabine si progression
LV5FU2 simplifié + cisplatine puis gemcitabine si progression
干预措施: gemcitabine hydrochloride (Drug)
LV5FU2 simplifié + cisplatine puis gemcitabine si progression
LV5FU2 simplifié + cisplatine puis gemcitabine si progression
干预措施: leucovorin calcium (Drug)
gemcitabine puis LV5FU2 simplifié + cisplatine si progression
gemcitabine puis LV5FU2 simplifié + cisplatine si progression
干预措施: cisplatin (Drug)
gemcitabine puis LV5FU2 simplifié + cisplatine si progression
gemcitabine puis LV5FU2 simplifié + cisplatine si progression
干预措施: fluorouracil (Drug)
gemcitabine puis LV5FU2 simplifié + cisplatine si progression
gemcitabine puis LV5FU2 simplifié + cisplatine si progression
干预措施: gemcitabine hydrochloride (Drug)
gemcitabine puis LV5FU2 simplifié + cisplatine si progression
gemcitabine puis LV5FU2 simplifié + cisplatine si progression
干预措施: leucovorin calcium (Drug)
结局指标
主要结局
Overall survival
时间窗: 2012
次要结局
- Progression-free survival(2012)
- Quality of life(2012)
- Percentage of patients needing second-line therapy(2012)
- Duration of hospitalization(2012)
- Toxicity(2012)