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Perioperative Chemotherapy Compared To Neoadjuvant Chemoradiation in Patients With Adenocarcinoma of the Esophagus
Sponsor: University Hospital Schleswig-Holstein
Summary
The trial is designed to investigate differences in outcome of patients with esophageal adenocarcinoma and junctional adenocarcinoma treated with perioperative (neoadjuvant + adjuvant) chemotherapy (FLOT) plus surgical resection versus neoadjuvant chemoradiation (CROSS) plus surgical resection.
Official title: Perioperative Chemotherapy (FLOT Protocol) Compared To Neoadjuvant Chemoradiation (CROSS Protocol) in Patients With Adenocarcinoma of the Esophagus
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
438
Start Date
2016-01
Completion Date
2024-12-31
Last Updated
2024-05-08
Healthy Volunteers
No
Interventions
5-Fluorouracil
2600 mg/m² (24 hours), d1 every two weeks;
Leucovorin
200 mg/m² in 250 ml NaCl 0.9%, d1 every two weeks;
Oxaliplatin
85 mg/m² in 500 ml G5% over 2h, d1 every two weeks;
Docetaxel
50mg/m2 in 250 ml NaCl 0.9% over 1h, d1 every two weeks;
Carboplatin
Dose-dependant: 2mg/ml/min AUC in 500ml Glucose 5%, day 1, 8, 15, 22 and day 29.
Paclitaxel
50mg/m2 in 500ml NaCl 0.9% over 1 h, day 1, 8, 15, 22 and day 29;
Neoadjuvant radiation
41.4Gy given in 23 fractions of 1.8Gy on days 1-5, days 8-12, days 15-19, days 22-26 and days 29-31.
Locations (30)
Uniklinik RWTH Aachen
Aachen, Germany
Charité Berlin - Campus Benjamin Franklin (CBF)
Berlin, Germany
Charité Berlin Campus Virchow-Klinikum (CVK)
Berlin, Germany
Uniklinik Köln
Cologne, Germany
Klinikum Dortmund gGmbH
Dortmund, Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Universitätsmedizin Göttingen
Göttingen, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitätsklinikum des Saarlandes
Homburg, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Germany
Universitätsklinikum Magdeburg
Magdeburg, Germany
Universitätsmedizin Mainz
Mainz, Germany
Universitätsklinikum Mannheim GmbH
Mannheim, Germany
Johannes Wesling Klinikum Minden
Minden, Germany
Klinikum der Universität München (LMU)
München, Germany
Universitätsklinikum Münster
Münster, Germany
Ruppiner Kliniken GmbH
Neuruppin, Germany
Sana Klinikum Offenbach GmbH
Offenbach, Germany
Universitätsklinikum Regensburg
Regensburg, Germany
Universitätsmedizin Rostock
Rostock, Germany
Klinikum Stuttgart
Stuttgart, Germany
Robert-Bosch-Krankenhaus Stuttgart
Stuttgart, Germany
Klinikum Mutterhaus
Trier, Germany
Universitätsklinikum Würzburg
Würzburg, Germany