European Study Group For Pancreatic Cancer - Trial 3
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,030
- 试验地点
- 27
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective, or whether chemotherapy is more effective than observation, in treating pancreatic cancer after surgery.
PURPOSE: Phase III trial to compare the effectiveness of two chemotherapy regimens with no further therapy in treating patients who have completely resected pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy of adjuvant gemcitabine vs fluorouracil and leucovorin calcium (vs observation only in patients with ampullary or other pancreatic malignancy), in terms of overall survival, in patients with completely resected pancreatic cancer.
Secondary
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life and 5-year survival of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
Arm I
Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.
干预措施: fluorouracil (Drug)
Arm I
Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.
干预措施: leucovorin calcium (Drug)
Arm II
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15.
干预措施: gemcitabine hydrochloride (Drug)
Arm III
Patients undergo observation.
干预措施: clinical observation (Other)
结局指标
主要结局
Overall survival
次要结局
- Survival rate at 2 and 5 years
- Toxicity as measured by NCI CTC v2.0
- Quality of life as measured by EORTC QLQ C-30 and ESPAC-QLQ at 3, 6, and 12 months, and then annually for 5 years