EUCTR2010-018754-13-DE进行中（未招募）1 期
A randomized multicenter Phase II/III Study comparing 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) versus Epirubicin, Cisplatin and 5-FU (ECF) in patients with locally advanced resectable adenocarcinoma of the esophagogastreal junction or the stomach - FLOT4
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 714
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
入选标准
- •locally advanced (>T1) and/or nodal positive (N+) histologically confirmed adenocarcinoma of the esophagogastreal junction (AEG I-III) or stomach without distant metastases (M0) or infiltration of adjacent structures or organs
- •no previous resection of the tumor
- •no previous cytostatic chemotherapy
- •Age > 18 years (female and male).
- •medical operability
- •In case of a clinical suspicion of peritoneal carcinomatosis an exclusion of this diagnosis via laparoscopy is required.
- •Leucocytes > 3.000/µl
- •Platelets > 100.000/µl
- •Serum creatinin = 1.5x of normal value, or Creatinin-Clearance > 40 ml/min
- •normal ejection fraction in ECG
- •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 714
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 714
排除标准
- •metastases or infiltration of adjacent structures or organs and all primarily not resectable stages
- •Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin, Epirubicin, Docetaxel and, if applicable, Capecitabine
- •Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin, Epirubicin, Docetaxel and, if applicable, Capecitabine
- •Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA
- •malignant secondary disease, dated back < 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma)
- •severe non-surgical accompanying disease or acute infection
- •peripheral polyneuropathy > NCI Grad II
- •severe liver dysfunction (AST/ALT>3,5xULN, AP>6xULN, Bilirubin>1,5xULN)
- •chronic inflammable gastro-intestinal disease
- •inclusion in another clinical trial
- •pregnancy or lactation
研究者
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