Description:

Responsible Party: Prof. Dr. Jens Hoeppner, Head of Upper GI Surgery Programm, University Hospital Freiburg ClinicalTrials.gov Identifier: NCT02509286 History of Changes Other Study ID Numbers: P000760 2015-001683-20 ( EudraCT Number ) DRKS00008008 ( Registry Identifier: DRKS ) Study First Received: July 22, 2015 Last Updated: April 12, 2017 Perioperative Chemotherapy Compared To Neoadjuvant Chemoradiation in Patients With Adenocarcinoma of the Esophagus (ESOPEC) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02509286

Link:

https://clinicaltrials.gov/ct2/show/NCT02509286

Keywords:
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  1. 7/4/17
Uploaded on:

July 4, 2017

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License:
Creative Commons BY 4.0
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Eligibility Esophagus Adenocarcinoma DRKS00008008 NCT02509286 DRKS00008008

Eligibility Esophagus Adenocarcinoma NCT02509286 DRKS00008008

Inclusion Criteria
Histologically verified adenocarcinoma of the esophagus according to the UICC definition (TNM7)
Pre-treatment stage cT1N+, M0 or cT2-4a, N0/+, M0
Age ≥18 years
No prior abdominal or thoracic radiotherapy
ECOG Performance status 0-2
Adequate cardiac function ( Patients with a cardiac history (e.g. myocardial infarction, heart failure, coronary artery disease) should have a cardiology review)
Adequate bone marrow function (WBC>3x10^9/l; Hb>9g/dl; platelets >100x10^9/l)
Adequate respiratory function. Symptomatic Patients should have pulmonary function tests with FEV1>1,5l )
Adequate renal function (GFR >60ml/min)
Adequate liver function (serum bilirubin <1.5x Upper level of Normal (ULN); AST <2.5x ULN and ALT <3x ULN (ULN as per institutional standard)
Written informed consent
Exclusion Criteria
Tumors of squamous or other non-adenocarcinoma histology
Patients with advanced inoperable or metastatic esophageal adenocarcinoma
Stage cT1N0 and cT4b
Gastric carcinoma
Prior chemotherapy for cancer,
Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months)
Clinical significant lung disease (FEV 1<1,5l)
Peripheral neuropathy Grade >1
Healthy Volunteers