EUCTR2013-003972-11-DE进行中（未招募）1 期
Randomized multicenter phase II/III study with adjuvant gemcitabine versus neoadjuvant/adjuvant FOLFIRINOX in resectable pancreatic cancer - NEPAFOX
Institut für Klinisch-Onkologische Forschung Krankenhaus Nordwest GmbH0 个研究点目标入组 126 人开始时间: 2014年2月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Histologically confirmed adenocarcinoma of the pancreas
- •2.Radiological confirmation of a local curative resectable (primarily resectable or borderline situation) pancreas carcinoma without distant metastases
- •3.no prior pancreas resection
- •4. no prior cytostatic chemotherapy
- •5. Male and female patients aged = 18 and = 75 years
- •6. ECOG = 1
- •7. medical operability
- •8. Granulocytes > 1.500/µl
- •9. Thrombocytes > 100.000/µl
- •10. Hemoglobin = 8,0 g/dl
- •11. Serumcreatinine = 1.5x of normal value or Creatinine-Clearance > 50 ml/min
- •12. Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 126
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 126
排除标准
- •1. Endocrine pancreas carcinoma
- •2. Locally advanced inoperable stages
- •3. distant metastases
- •4. relapse
- •5. prior radiotherapy of the measurable lesions
- •6. Peritoneal carcinomatosis
- •7. Malignant secondary disease dating back < 5 years (exceptions: in situ cervical carcinoma, appropriately treated basal cell carcinoma of the skin)
- •8. contraindication to operative resection
- •9. ECOG = 2
- •10. Severe hepatic impairment (AST/ALT>3,5xULN, AP>6xULN)
- •11. transhepatic drainage
- •12. Active CAD, cardiomyopathy or NYHA stage III-IV heart failure and EF < 45%
- •13. severe internal diseases or acute infection
- •14. chronic diarrhea
- •15. chronic inflammatory bowel disease
- •16. Peripheral polyneuropathy > NCI grade II
- •17. Pregnancy or lactation
- •18. hypersensitivity or contraindication to Gemcitabine, Oxaliplatin, Natrium folinate, Irinotecan, 5-Fluorouracil
- •19. Participation in another interventional study
研究者
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