NCT00490360已完成2 期
Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2,007
- 试验地点
- 1
- 主要终点
- Resectability rate > 70% after restaging
研究概览
简要总结
Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head.
详细描述
Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head. Two cycles of chemotherapy are given on day 1 and 15 each. After restaging excludes disease progression, a standard Whipple procedure is performed.
Staging and restaging procedures include abdominal CT, diagnostic laparoscopy, PET/CT, tumor markers (CEA, CA 19-9) and assessment of the quality of life by the QLQ-30.
- Trial with medicinal product
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
- •Age > 18 years
- •Histologically or cytologically confirmed resectable ductal adenocarcinoma of the pancreatic head
- •WHO-performance status 0-2
- •Written informed consent
- •Discussion in an intrdisciplinary conference
排除标准
- •Insufficient renal function (calculated creatinin clearance < 60ml(min)
- •Insufficient hematologic function (neutrophil count <1'000/ul, platelets < 100'000/ul)
- •Uncorrectable coagulopathy
- •Severe cholestasis (bilirubin >100mmol/l)
- •Distant metastases in liver, lungs or other organs
- •Peritoneal carcinomatosis
- •Unresectable tumor (s. 4.2.)
- •Contraindication for Whipple procedure
- •Uncontrolled infection
- •Neurotphil count > °2
- •Estimated life experience < 6 months
- •HIV Infection
- •Severe medical or psychatric comorbidities which interefere with the participation in this trial or the informed consent
- •Female patients in child-bearing age without adequate contraception
结局指标
主要结局
Resectability rate > 70% after restaging
时间窗: 2007
次要结局
未报告次要终点
研究者
研究点 (1)
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