Status:
COMPLETED
Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction
Lead Sponsor:
Technical University of Munich
Conditions:
Adenocarcinoma of the Esophagogastric Junction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 metabolica...
Detailed Description
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 inciden...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 5 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2020
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT02287129
Start Date
December 5 2014
End Date
August 7 2020
Last Update
November 28 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
2nd department of the Medical Clinic of the Technical University Munich
Munich, Bavaria, Germany, 81675