EUCTR2008-007546-56-DE进行中（未招募）不适用
A Phase II Multicentre Study of perioperative Chemotherapy for resectable Adenocarcinoma of the Gastroesophageal Junction and of the Stomach
Klinikum der Universität München, Campus Großhadern0 个研究点开始时间: 2009年8月21日最近更新:
相关药物
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
- •By means of push-endoscopy (PE) histologically confirmed adenocarcinoma of the gastroesophageal junction (GEJ I-III) and the stomach (every T, N + T3/T4, Nx, M0)
- •Signed written consent of the patient
- •Age = 18
- •Expectedness that surgery may be performed
- •ECOG-Performance-Status = 2
- •Laparoscopic exclusion of peritoneal carcinoma
- •Adequate haematological, renal, cardiac and hepatic function: leukocytes = 3.0 * 109/l; neutrophiles = 1.5 * 109/l; thrombocytes = 100* 109/l; haemoglobin = 9.7 g/dl; serum creatinine 1.25 * upper limit of the normal range (ULNR) or creatinine clearance > 60 ml/min; serum bilirubin = 1.25 * ULNR; ALAT and ASAT = 1. 5 * ULNR
- •Effective contraceptive measures for men and women
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pre-existing chemotherapy or radiotherapy for the gastroesophagal junction or the adenocarcinoma
- •Non-histologically confirmed primary tumor
- •Distant metastasis
- •Known hypersensitivity against 5-Flourouracil, Leucovorin, Oxaliplatin or Docetaxel
- •Known dihydropyrimdine dehydrogenase (DPD) deficiency
- •Peripheral polyneuropathy = grade II (NCI-CTCAE, version 3.0)
- •Myocardial infarction in the last 3 months, heart insufficiency grade II-IV (NYHA)
- •Severe concomitant diseases or acute infections
- •Known drug usage or medication abuse
- •Pregnant or lactant women
- •Insufficient contraception
- •A simultaneous or within a time period of 30 days, participation in studies with one or multiple number of drugs under investigation
- •Second neoplasia = 5 years prior study entry (exception: carcinoma in situ of the cervix uteri and an adequately treated basal cell carcinoma)
- •Missing or limited contractual capability
研究者
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