EUCTR2014-000860-16-DE
Active, not recruiting
Phase 1
Metabolic and Molecular Response Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction - MEMORI
Technische Universität München Fakultaet fuer Medizin0 sites120 target enrollmentMarch 17, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Technische Universität München Fakultaet fuer Medizin
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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