702
Participants
Start Date
November 5, 2020
Primary Completion Date
September 15, 2023
Study Completion Date
September 15, 2028
Oxaliplatin, 85 mg/m2
85 mg/m2,2h-civ, day 22, 36, 50, 64, 78, 92, 106, 120, and 134 of therapy
5FU; 2400 mg/m2
2400 mg/m2, 46h-civ, day 22, 36, 50, 64, 78, 92, 106, 120, 134 of therapy for Control arm
5FU, 250 mg/m2
250 mg/m2 per day, civ, on day 1-14, day 22-35 of radiotherapy;
5FU, 2400 mg/m2
2400 mg/m2,46h-civ, d64, d78, d92, d106, d120, d134 of therapy
Oxaliplatin 50 mg/m2
50 mg/m2, 2h-civ, d1, d8, d21, d29 of radiotherapy and
Folinic Acid, 400 mg/m2
2h-civ day 22, 36, 50, 64, 78, 92, 106, 120, and 134 of therapyfor Control arm; 400 mg/m2, 2h-civ d 64, d78, d92, d106, d120, d134 of therapy for experimental arm
Radiotherapy control, 5x5 Gy: 25 Gy
Control arm: 5x5 Gy (total: 25 Gy) 5 fractions
Capecitabine, 1000 mg/m2
1000 mg/m2 (twice daily) day1-14 every three weeks instead of 5FU optional
Oxaliplatin 85 mg/m2
85 mg/m2, 2h-civ, d64, d78, d92, d106, d120, d134 of therapy
radiotherapy experimental, 30 x 1,8 Gy: 54 Gy
30 x 1.8 Gy (total: 54 Gy), 5 fractions per week
Capecitabine, 825 mg/m2
825 mg/m2 bid, per os, on day 1-14, 22-35 of RT instead of 5FU optional
Oxaliplatin, 130 mg/m2
day1every three weeks (optional)
Vivantes Clincial Center in Friedrichshain, Berlin
Clincal Center Helios Berlin Buch, Berlin
Ev. Waldkrankenhaus, Spandau,, Berlin
Helios Klinikum Berlin Emil von Behring, Berlin
Clincal Center Helios Bad Saarrow, Bad Saarow
Dietrich Bonhoeffer Klinik, Neubrandenburg
University Clinic Rostock, Rostock
Uniklinik Schleswig Holstein, Lübeck
University Clinic Kiel, Kiel
Pius Hospital, Oldenburg, Oldenburg
University Clinic Oldenburg, Oldenburg
Oncology UnterEms, Leer, Leer
Medical Project Hannover, Hanover
"St. Bernward Clincal Center Hildesheim", Hildesheim
Oncology in Medicinum Hildesheim, Hildesheim
Hematological-Oncological Practice Dr. Oleg Rubanov, Hameln, Hamelin
Clinic Lippe GmbH (Lemgo/Detmold), Detmold
Brother clinic St. Josef, Paderborn, Paderborn
St. Vincenz Hospital Paderborn, Paderborn
Klinikum Bielefeld, Bielefeld
Franziskus Hospital Bielefeld, Bielefeld
DRK Clincal Centers North Hessen Kassel, Kassel
University Clinic Marburg, Marburg
Praxis für Hämatologie und Onkologie, Giessen
Lahn-Dill Clinics Wetzlar, Wetzlar
Clinic Fulda, Fulda
University Clinic Göttingen, Göttingen
Clinic Wolfsburg, Wolfsburg
MVZ Oncological Cooperation Harz, Goslar
University Clinic Magdeburg, Magdeburg
Clinic Maria Hilf GmbH, Mönchengladbach
St. Josef Hospital of the catholic clinic Bochum, Bochum
Hospital Bochum, Bochum
University Clinic Essen, Essen
"Clinical Center Essen Mitte", Essen
Prosper Hospital Recklinghausen, Recklinghausen
Evangelical Clinic Wesel, Wesel
Alexianer Krefeld GmbH / Maria Hilf Krankenhaus, Krefeld
Mathias-Spital, Rheine, Rheine
"Clinical Center Mutterhaus Trier", Trier
University Clinic Mainz, Mainz
Clinic North West gGmbH Frankfurt, Frankfurt am Main
Department of Radiooncology, Frankfurt
Sana Clinical Center Offenbach, Offenbach
Clincal Center Darmstadt, Darmstadt
Onkologische Schwerpunktpraxis, Darmstadt
CaritasClinic Saarbrücken, Saarbrücken
Med. Statistik Saarbrücken GgR, Saarbrücken
University Clinic Mannheim, Mannheim
Clinic Stuttgart, Stuttgart
University Clinic for Radioncology Tübingen, Tübingen
Clinic Ostlab, Staufenclinic Schwaeb.Gmuend, Mutlangen, Mutlangen
Clincal Center Esslingen, Esslingen am Neckar
Medius Clincal Center Ostfildern-Ruit, Ostfildern
Pi.Tri-Studien GmbH, Offenburg, Offenburg
Schwarzwald-Baar-Kliniken, Villingen-Schwenningen
University Clinic Freiburg, Freiburg im Breisgau
Technical University Clinic Munich, München
Technical University Munich, München
"Clincal Center Bogenhausen Munich", München
Klinikverbund Allgäu, Kempten (Allgäu)
University Clinic Ulm, Ulm
University Clinic Erlangen, Erlangen
"Clincal Center St. Marien Amberg", Amberg
Clinic Nordoberpfalz AG, Clinic Weiden, Weiden
"Hospital Barmherzige Brüder Regensburg", Regensburg
University Clinic Regensburg, Regensburg
Clinic Bayreuth GmbH, Bayreuth
Clinical Center Coburg, Coburg
University Clinic Würzburg, Würzburg
Clincal Center Chemnitz, Chemnitz
Radiotherapy Practice Dr. A. Schreiber, Dresden, Dresden
Oncology Practice Dresden, Dresden
University Clinic Leipzig, Leipzig
Clinic Sankt Georg gGmbH, Leipzig, Leipzig
Universitätsklinikum Halle, Halle
Prof. Dr. med. Claus Rödel
OTHER