830
Participants
Start Date
April 4, 2013
Primary Completion Date
February 2, 2021
Study Completion Date
November 8, 2023
Induction chemotherapy with gemcitabine or FOLFIRINOX
According to medical recommendation, induction chemotherapy is performed with gemcitabine (3 cycles a 3 administrations, 1000 mg/m\^2/d)or FOLFIRINOX (6 cycles; 1 cycle: oxaliplatin 85 mg/m\^2 2 h infusion, folinic acid 400 mg/ m\^2 2h infusion completed after 30 min with irinotecan infusion 180 mg/m\^2 for 90 minutes, bolus application 5-FU 400 mg/m\^2 followed by 46h infusion of 5-FU 2400 mg/m\^2)
Radiotherapy, 28 x 1.8 Gy
Radiotherapy combined with chemotherapy starts on day 1 of chemotherapy. Radiation volume is restricted to macroscopic visual tumor region. Radiation is performed in 28 fractions with 1.8 Gy resulting in a total dose of 50.4 Gy.
Chemotherapy, gemcitabine
5 cycles of 300 mg/m\^2/d gemcitabine infusions and than 3 administrations of 1000 mg/m\^2/d
Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy
Chemotherapeutic administration started with during induction chemotherapy is continued; Gemcitabine: 3 cycles a 3 administrations of 1000 mg/m\^2/d gemcitabine infusions FOLFIRINOX: 6 cycles
Oldenburg Pius Hospital, Oldenburg
Leer MVM, Leer
Göttingen Universitätsmedizin, Göttingen
Magdeburg Universitätsklinikum, Magdeburg
Magdeburg Klinikum, Magdeburg
Bochum, Augusta-Kranken-Anstalt, Hämatologie/Onkologie, Bochum
Bochum, St. Josef-Hospital, Bochum
Münster Universitätsklinikum, Münster
Köln Universitätsklinikum, Cologne
Frankfurt/Main Universitätsklinikum, Frankfurt am Main
Mannheim Universitätsmedizin, Mannheim
Heilbronn SLK-Kliniken, Heilbronn
Freiburg Universitätsklinikum, Freiburg im Breisgau
München Großhadern LMU, München
Erlangen Universitätsklinikum, Erlangen
Regensburg Krankenhaus Barmherzige Brüder, Regensburg
Regensburg Universitätsklinikum, Regensburg
Bayreuth, Klinikum, Bayreuth
Würzburg CCC Mainfranken, Würzburg
Dresden Onkologische Gemeinschaftspraxis, Dresden
Halle St. Elisabeth und St. Barbara Krankenhaus, Halle
Jena Universitätsklinikum, Jena
Leipzig UCCL, Leipzig
University of Erlangen-Nürnberg Medical School
OTHER