Randomized Phase II/III Trial Comparing Folririnox Association [Oxaliplatin / Irinotecan / LV5FU2] Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 342
- 试验地点
- 54
- 主要终点
- Objective response rate (Phase II)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy 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) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective as first-line therapy in treating pancreatic cancer.
PURPOSE: This randomized phase II/III trial is studying how well combination chemotherapy works as first-line therapy in treating patients with metastatic pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with oxaliplatin, irinotecan, leucovorin calcium, and fluorouracil vs gemcitabine as first-line chemotherapy. (Phase II)
- Compare the survival of patients treated with these regimens. (Phase III)
Secondary
- Compare the toxicity of these regimens in these patients.
- Compare progression-free survival of patients treated with these regimens. (Phase III)
- Compare the overall response rate in patients treated with these regimens. (Phase III)
- Compare quality of life of patients treated with these regimens. (Phase III)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Folfirinox
干预措施: fluorouracil (Drug)
Folfirinox
干预措施: irinotecan hydrochloride (Drug)
Folfirinox
干预措施: leucovorin calcium (Drug)
Folfirinox
干预措施: oxaliplatin (Drug)
Gemcitabine
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
Objective response rate (Phase II)
Survival (Phase III)
次要结局
- Overall response rate (Phase III)
- Toxicity
- Progression-free survival (Phase III)
- Quality of life (Phase III)