Phase II Study of FOLFOXIRI as Primary Treatment for Stage III Unresectable Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Radical resection rate
研究概览
简要总结
The study is conducted as a monocentric prospective phase II trial. Patients with unresectable stage III locally advanced pancreatic cancer (defined for extended encasement of superior mesenteric artery/celiac axis/hepatic artery or for combined venous and arterial involvement or for unreconstructible venous encasement), ECOG PS 0-1 and age 18-75 are eligible.
After multidisciplinary evaluation of resectability, treatment with FOLFOXIRI is provided for a maximum of 12 cycles with multidisciplinary evaluation of disease status every 4 cycle.
In case of tumors have deemed resectable surgery is considered. In case tumors remain unresectable, radiotherapy is evaluated after the end of chemotherapy.
Primary objective of the study is the rate of patients who become resectable and undergo radical surgical resection after chemotherapy.
Secondary objectives are: response rate, progression-free survival, overall survival, toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Stage III unresectable pancreatic cancer defined for:
- •extended encasement of superior mesenteric artery or celiac axis/hepatic artery
- •both arterial and venous (portal vein/superior mesenteric vein) encasement
- •unreconstructible vessel encasement
- •ECOG Performance Status 0-1
- •Age 18-75
- •Adequate liver, renal and bone marrow function
排除标准
- •Evidence of distant metastases
- •Cardiovascular diseases
- •Contraindications to studied drugs
研究组 & 干预措施
FOLFOXIRI
干预措施: FOLFOXIRI (Drug)
结局指标
主要结局
Radical resection rate
时间窗: 6 months
次要结局
- Progression-free survival(Within 24 months)
研究者
Enrico Vasile
MD, PhD
Azienda Ospedaliero, Universitaria Pisana