EUCTR2011-001856-12-CZ进行中（未招募）1 期
Early assessment of effectivness of neoadjuvant chemotherapy for carcinoma of the esophagus and esophago-gastric junction using FDG-PET/CT.
The Motol University Hospital0 个研究点开始时间: 2011年7月26日最近更新:
试验速览
- 阶段
- 1 期
- 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
- •age 18-75 years, males and females
- •histologically verified adenocarcinoma of the esophagus or esophago-gastric junction or proximal stomach affecting cardia
- •no distant metastases or non-regional lymph node metastasis on computed tomography of chest and abdomen
- •cT1, N1, M0-1a or cT2-T4 (potentially resectable tumor), N0-1, M0-1a (TNM staging AJCC 6th edition) on EUS and CT
- •performance status 0-1 (WHO)
- •medically fit for elective esophagectomy after neoadjuvant chemotherapy
- •signed 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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Patients with insulin-dependent diabetes mellitus or DM II on oral antidiabetics with glycemia level above 10 mmol/l
- •Patients with the finding of distant organ metastases at the inicial FDG-PET/CT will be excluded from the study
- •pregnant or nursing women
研究者
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