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

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Metabolic and Molecular Response evaluation for the individualization of therapy in adenocarcinomas of the gastroesophageal junction by evaluation of the R0 resection rate for patients with metabolically (ie, according to PET criteria) chemotherapy-resistant locally advanced AEG, who receive an intensified neoadjuvant chemoradiotherapy (INRCT). Additonal efforts will be done by investigation of molecular and metabolic biomarkers in relation to their predictive and prognostic value by correlating them with histopathologic responses and clinical outcome in an exploratory approach.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität München
• Treatments: Capecitabine; Carboplatin; Epirubicin; Fluorouracil; Oxaliplatin; Paclitaxel

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