EUCTR2014-000860-16-DE进行中（未招募）1 期
Metabolic and Molecular Response Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction - MEMORI
Technische Universität München Fakultaet fuer Medizin0 个研究点目标入组 120 人开始时间: 2014年3月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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 AEG I-III
- •Potentially R0 - resectable AEG and primary tumor category UT2 -4
- •Functional operability: Exclusion of OP - limiting comorbidities
- •Intense FDG tracer uptake of the tumor during Baseline PET/CT-) and thus suitability for monitoring and early response prediction by FDG - PET ( [ 18F ] - FDG uptake in the tumor at baseline > 1.35 x liver SUV + 2 x standard deviation of the liver SUV)
- •Performance status (ECOG ) 0 or 1
- •Age : = 18
- •creatinine clearance > 60ml/min, measured or calculated
- •bilirubin = 1.5 times upper limit of normal , serum transaminases (GOT / GPT ) = 3 times ULN
- •leukocytes = 3.5 g / l, platelet = 100 g / l
- •Negative pregnancy test (determination of beta- HCG in urine or serum) in women of childbearing potential
- •A signed consent form after implementation of medical education
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Existing distant metastases (M1b)
- •Tumor infiltration into the tracheobronchial system
- •Previous radiotherapy targeted at the thorax
- •Lack of ability of the patient to adhere to the protocol rules
- •Manifested heart failure despite of optimal medication> NYHA I
- •existing angina pectoris at rest or undergoing stress without clarification via interventional cardiology and / or myocardial infarction within the last 6 months
- •Existing pregnancy or lactation
- •childbearing or fertility without using recognized safe methods of contraception
- •Coexisting other malignant diseases with the exception of non- melanomatuous, localized skin tumor or carcinoma in situ of the cervix
- •absence of a signed consent form
研究者
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