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ACTIVE NOT RECRUITING
NCT02509286
PHASE3

Perioperative Chemotherapy Compared To Neoadjuvant Chemoradiation in Patients With Adenocarcinoma of the Esophagus

Sponsor: University Hospital Schleswig-Holstein

View on ClinicalTrials.gov

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

DRUG

5-Fluorouracil

2600 mg/m² (24 hours), d1 every two weeks;

DRUG

Leucovorin

200 mg/m² in 250 ml NaCl 0.9%, d1 every two weeks;

DRUG

Oxaliplatin

85 mg/m² in 500 ml G5% over 2h, d1 every two weeks;

DRUG

Docetaxel

50mg/m2 in 250 ml NaCl 0.9% over 1h, d1 every two weeks;

DRUG

Carboplatin

Dose-dependant: 2mg/ml/min AUC in 500ml Glucose 5%, day 1, 8, 15, 22 and day 29.

DRUG

Paclitaxel

50mg/m2 in 500ml NaCl 0.9% over 1 h, day 1, 8, 15, 22 and day 29;

RADIATION

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