NCT00286013已完成2 期
Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Feasibility
研究概览
简要总结
The aim of the study is to evaluate the feasibility defined as overall tolerance and toxicity as well as relative dose-intensity and cumulative dose delivered, of an association ofgemcitabine, oxaliplatin and radiotherapy in patients with locally advanced and unresectable, but non-metastatic pancreatic adenocarcinoma or cholangiocarcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven and unresectable adenocarcinoma of the pancreas or cholangiocarcinoma with no evidence of metastatic disease
- •WHO performance status of 0 or 1
- •Complete recovrey from surgery in case an enteric and/or biliary tract by-pass operation has been performed
- •Maximum delay after surgery: 8 weeks
- •No previous or co-existent malignant disease except non melanoma skin cancers and adequately treated cervic carcinoma in situ
- •Adequate bon marrow reserve
- •No previous chemotherapy or radiotherapy
- •Expected survival > 6 months
排除标准
- •Active infection
- •Metastatic disease
- •Inadequate liver function after derivative surgery
- •Inadequate renal function
- •Pregnancy, breast feeding
- •Use of any other investigational agent in the month before enrollment
- •Patients with grade 2 or more neuropathy
结局指标
主要结局
Feasibility
Tolerance
次要结局
未报告次要终点
研究者
研究点 (4)
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