311
Participants
Start Date
March 25, 2015
Primary Completion Date
September 30, 2018
Study Completion Date
June 16, 2023
Induction Chemotherapy arm A
"Patients receive three induction chemotherapy cycles, starting on day 1, 15 and 29, consisting of:~Folinic acid: 400 mg/sqm, 2h-iv; Oxaliplatin: 100 mg/sqm, 2h-iv; 5-FU: 2400 mg/sqm, 46h-iv~After a break of two weeks, radiotherapy starts combined with:~5-FU: 250 mg/sqm per day, iv, on day 43-57, day 64-77 Oxaliplatin: 50 mg/sqm, day 43, 50, 64, and 71"
Radiation arm A
Radiotherapy: 28 x 1.8 Gy (total: 50.4 Gy), 5 fractions per week on day 43 -80
Radiation arm B
Radiotherapy: 28 x 1.8 Gy (total: 50.4 Gy), 5 fractions per week on day 1- 38
Chemotherapy arm B
"chemoradiotherapy is started according to the following schedule: 5-FU: 250 mg/sqm per day, iv, on day 1-14, day 22-35; Oxaliplatin: 50 mg/sqm, day 1, 8, 22, and 29.~After a break of two and a half weeks, patients receive three chemotherapy cycles, starting on day 57, 71 and 85, consisting of:~Folinic acid: 400 mg/sqm, 2h-iv; Oxaliplatin: 100 mg/sqm, 2h-iv; 5-FU: 2400 mg/sqm, 46h-iv"
Surgery
Surgery should be performed about 5 (arm B) or 6 (arm A) weeks after the last radiation or chemotherapy, i.e. around day 123
University Hospital Frankfurt Goethe University, Frankfurt
University Clinic, Erlangen
RWTH Aachen, Aachen
University Clinic, Bochum
Clinic for Radiotherapy, Chemnitz
Diacura Clinic for Radiotherapy, Coburg
Internist Practice, Dresden
University Clinic, Dresden
University Clinic, Esslingen am Neckar
University Clinic, Freiburg im Breisgau
HELIOS Park-Klinikum Leipzig, Leipzig
University Clinic, Leipzig
University Clinic, Mannheim
Hospital Miria Hilf, Mönchengladbach
Pius Hospital Oldenburg, Oldenburg
University Clinic, Oldenburg
Hospital Barmherziger Brueder, Regensburg
University Clinic, Regensburg
University Clinic, Rostock
University Clinic, Würzburg
Johann Wolfgang Goethe University Hospital
OTHER
Deutsche Krebshilfe e.V., Bonn (Germany)
OTHER
Prof. Dr. med. Claus Rödel
OTHER