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临床试验/ISRCTN02140505
ISRCTN02140505已完成2 期

A Prospective, Randomised trial Of Simultaneous Pancreatic cancer treatment with Enoxaparin and ChemoTherapy

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)0 个研究点目标入组 312 人开始时间: 2007年12月21日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
312

研究概览

简要总结

2008 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/19055847 protocol 2015 Results article in https://pubmed.ncbi.nlm.nih.gov/25987694/ (added 27/10/2022)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •1. Histologically or cytologically proven advanced pancreatic cancer stage Iva, b
  • •2. No previous tumour specific therapy of the main tumor or distant metastases
  • •3. Karnofsky Performance Status (KPS) greater than 50%
  • •4. Measurable disease visible per computed tomography (CT) or magnetic resonance tomography (MRT) not older than 14 days
  • •5. No previous deep vein thrombosis (DVT) of the legs within last two years
  • •6. Leucocytes greater than 3.5 x 10^9/L, platelets greater than 100 x 10^9/L
  • •7. Written informed consent
  • •8. Age of 18 years or more
  • •9. Sufficient contraception up to six months after the end of therapy

排除标准

  • •1. Indication for anticoagulation therapy
  • •2. Previous bleeding within two weeks before or increased danger of bleeding
  • •3. Body weight less than 45 kg or greater than 100 kg
  • •4. Pregnant or breastfeeding women
  • •5. Heavy disorders, contradictory with study (as decided by physician)
  • •6. Hyperesthesia against study medication or related drugs
  • •7. Patients with renal failure (creatinine clearance less than 30 ml/min)

研究者

发起方
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

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