Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction

Launched by TECHNICAL UNIVERSITY OF MUNICH · Nov 7, 2014

Keywords

ClinConnect Summary

Adenocarcinomas of the esophagus and the esophagogastric junction (AEG) are clinically-topographically divided into subtypes I-III according to the Siewert classification and show an increased incidence. Neoadjuvant and/or perioperative chemotherapy or preoperative radiochemotherapy is well established in the management of AEG. However, a significant number of patients do not respond to preoperative chemotherapy, suffering from toxicity and facing a worse outcome due to lower R0 resection rates. Previous results from the MUNICON-1 and MUNICON-2 trials have shown that PET-based therapy indiv...

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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 examination 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 in a 24 h urine or calculated with the Cockgroft -Gault formula
• • 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
• 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
• • Manifest heart failure despite 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 a non-melanomatuous, localized skin tumor or carcinoma in situ of the cervix
• • absence of a signed consent form