EUCTR2012-000640-10-GB进行中（未招募）不适用
A randomised Phase II study of two pre-operative chemoradiotherapy regimes (oxaliplatin and capecitabine followed by radiotherapy with either oxaliplatin and capecitabine or paclitaxel and carboplatin) for resectable oesophageal cancer. - NeoSCOPE: Neo-adjuvant Study of Chemoradiotherapy in OesoPhagEal Cance
Velindre NHS Trust0 个研究点开始时间: 2012年12月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Histologically confirmed operable oesophageal cancer (adenocarcinoma) Tumour must be staged as a T3, 4 or N1 (using TNM6 staging) or T3, T4a or N1-3 using TNM7 staging) Maximum disease (Tumour plus nodes) length 8 cm staged with EUS and CT/PET WHO performance status 0-1 Adequate haematological, renal, respiratory, cardiac and hepatic function The patient has provided written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Histologically confirmed operable oesophageal cancer (squamous cell carcinoma) Uncontrolled angina pectoris, myocardial infarction within 6 months, heart failure, clinically significant uncontrolled cardiac arrhythmias, or any patient with a clinically significant abnormal ECG. Patients with any previous treatment for oesophageal carcinoma. Siewert type 3 oesophago-gastric tumours. T4 tumours invading contiguous structures other than diaphragm, crura or mediastinal pleura. Patients with disease in any of the following areas on the CT scan, EUS or other staging investigation: Evidence of other distant metastases. Para-aortic lymphadenopathy >1cm diameter on CT or >6mm diameter on EUS. Invasion of tracheo-bronchial tree, aorta, pericardium or lung. Lymphadenopathy encasing the coeliac axis (as described above, patients with single nodes lying anterior to the origin of the splenic artery and anterior to the origin of the coeliac axis are not excluded). Any patient with a single significant medical condition which is thought likely to compromise his or her ability to tolerate any of the above therapies. Specific contra-indications to surgery, chemotherapeutic agents (including known allergies to chemotherapy) or radiotherapy. Pregnant or lactating women and fertile women who will not be using adequate contraception during the trial.
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