ISRCTN01852072已完成3 期
A randomised controlled trial comparing standard chemotherapy followed by resection versus Epirubicin, Cisplatin and Xeloda (ECX) chemotherapy followed by resection in patients with resectable adenocarcinoma of the oesophagus
Medical Research Council (MRC) (UK)0 个研究点目标入组 897 人开始时间: 2004年8月3日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 897
研究概览
简要总结
2015 Abstract results in https://doi.org/10.1093/annonc/mdv262.03 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28784312 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histologically verified adenocarcinoma of the oesophagus or type 1 and type 2 adenocarcinoma of the oesophago-gastric junction
- •2. Adenocarcinoma as above, which includes disease staged as T1 N1, T2 N1, T3 N0, and T3 N1 as assessed by spiral computed tomography (CT) or endoscopic ultrasound. T4 tumours that involve only the diaphragm or crura as well as T4 tumours invading the mediastinal pleura only.
- •3. Tumours with nodal disease (N1) affecting the origin of the left gastric and splenic artery with the coeliac axis (hitherto staged as M1a)
- •4. World Health Organisation (WHO) performance status 0 or 1
- •5. Proven respiratory cardiac, hepatic, renal and haematological function to the following levels: forced expiratory volume in 1 second (FEV1) >1.5 litres; cardiac ejection fraction >50% of normal echocardiography; liver function tests not more than 1.5 x normal; glomerular filtration rate =60 ml/min; white blood cell count >3 x 10^9/l; platelets >100 x 10^9/l (from the time diagnosis of cancer was first suspected).
- •6. Written informed consent
排除标准
- •Does not match inclusion criteria
研究者
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