ISRCTN78805636已完成不适用
Preoperative chemoradiation in locally resectable adenocarcinoma of pancreatic head without metastasis
Friedrich-Alexander University Erlangen-Nuremberg - Medical Faculty (Germany)0 个研究点目标入组 254 人开始时间: 2005年4月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 254
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adenocarcinoma of pancreatic head, histologically or cytologically proven, resectable as assessed by computed tomography (CT)-scan (major vessels [V. portae, confluence of V. mesenterica and lienalis, A. mes. sup., Truncus coeliacus, A. lienalis, A. hepatica, V. mes. sup.] maximally enclosed up to 180° by the tumour)
- •2. No infiltration of extrapancreatic organs (exception: duodenum)
- •3. Only one peripancreatic lymph node (LN) greater than 1 cm on CT-scan (amendment July 11 2005 - this criterion was removed)
- •4. No metastasis
- •5. No peritoneal carcinosis (laparoscopy facultative)
- •6. Age between 18 and 75 years (amendment July 11 2005 - aged 18 or over)
- •7. Good performance (Karnofsky-index greater than 60)
- •8. No previous treatment for carcinoma of pancreas
- •9. No previous malignant disease (exception: non-melanomatous skin tumour, carcinoma in situ of cervix uteri, malignant disease in complete remission treated only surgically at least ten years ago)
- •10. No participation in other clinical trial in the last three months before randomisation
- •11. No liver cirrhosis (Quick greater than 70%, thrombocytes greater than 100,000 mm^3)
- •12. Serum-creatinine less than 1.5 mg/dl; creatinine-clearance greater than 70 ml/min
- •14. No severe cardiopulmonal disease or any disease which renders the patient not suitable for one treatment option
- •15. No human immunodeficiency virus (HIV)-infection
- •16. No lack of judiciousness
- •17. Written informed consent by the patient
排除标准
- •1. Ampullary carcinoma (tumours origination from the ampulla, the papilla or at the junction of the ampulla and the papilla)
- •2. Carcinoma of the pancreatic corpus or tail (tumours between the left edge of the superior mesenteric vine and the left edge of the aorta respectively between the left edge of the aorta and the splenic hilum)
- •3. Non-ductal adenocarcinoma of the pancreas (e.g. cystadenocarcinoma, neuroendocrine tumours, etc.)
- •4. Pregnancy or insufficient contraception
- •5. Aged less than 18 years
- •6. Karnofsky performance status less than 70
- •7. Doubtful understanding or contractual capacity of the patient
研究者
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