EUCTR2006-006936-24-DE进行中（未招募）不适用
A multicenter, randomised phase II trial on the therapy of advanced gastric cancer or adenocarcinoma of the esophagogastric junction in patients older than 65 years with special regard on quality of life and the pharmacogenetic risk profile - FLOT65+
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108
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
- •metastatic, locally advanced or refractory gastric cancer or adenocarcinoma of the esophagogastric junction
- •no previous chemotherapy in metastatic state
- •patients (male and female) older than 65 years
- •ECOG 0, 1 or 2
- •Leucocytes > 3000/µl
- •Thrombocytes >100000/µl
- •Creatinine serum level < 1,5x ULN or Creatinine clearance > 40 ml/min
- •signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Hypersensitivity for 5-Fluorouracil, Leucovorin, Oxaliplatin or Docetaxel
- •KHK, cardiomyopathy or cardiac insufficiency II-IV (NYHA)
- •second malignancy <5years ago
- •brain metastases
- •severe internal dysfunction or acute infection
- •peripheral polyneuropathie >NCI grade II
- •impairment of liver function (AST/AKT>3,5xULN, AP>6xULN, Bilirubin>1,5xULN)
- •chronic intestinal inflammation
- •participation in another clinical trial
研究者
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