Metabolic and Molecular Response Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junctio

Phase 1

• Conditions: Histologically confirmed adenocarcinoma of the oesophagogastric junction (AEG) (ICD-classification: C15.5 / C16.0); MedDRA version: 20.0Level: LLTClassification code 10018017Term: Gastrointestinal tract cancer NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000860-16-DE
• Lead Sponsor: Technische Universität München Fakultaet fuer Medizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-17
• Last Update Posted: 23 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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
• 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified