Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy

PHASE3CompletedINTERVENTIONAL
Enrollment

830

Participants

Timeline

Start Date

April 4, 2013

Primary Completion Date

February 2, 2021

Study Completion Date

November 8, 2023

Conditions
Pancreatic Cancer
Interventions
DRUG

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)

RADIATION

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.

DRUG

Chemotherapy, gemcitabine

5 cycles of 300 mg/m\^2/d gemcitabine infusions and than 3 administrations of 1000 mg/m\^2/d

DRUG

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

Trial Locations (23)

26121

Oldenburg Pius Hospital, Oldenburg

26789

Leer MVM, Leer

37075

Göttingen Universitätsmedizin, Göttingen

39120

Magdeburg Universitätsklinikum, Magdeburg

39130

Magdeburg Klinikum, Magdeburg

44791

Bochum, Augusta-Kranken-Anstalt, Hämatologie/Onkologie, Bochum

Bochum, St. Josef-Hospital, Bochum

48149

Münster Universitätsklinikum, Münster

50937

Köln Universitätsklinikum, Cologne

60590

Frankfurt/Main Universitätsklinikum, Frankfurt am Main

68167

Mannheim Universitätsmedizin, Mannheim

74078

Heilbronn SLK-Kliniken, Heilbronn

79106

Freiburg Universitätsklinikum, Freiburg im Breisgau

81377

München Großhadern LMU, München

91054

Erlangen Universitätsklinikum, Erlangen

93049

Regensburg Krankenhaus Barmherzige Brüder, Regensburg

93053

Regensburg Universitätsklinikum, Regensburg

95445

Bayreuth, Klinikum, Bayreuth

97080

Würzburg CCC Mainfranken, Würzburg

01307

Dresden Onkologische Gemeinschaftspraxis, Dresden

06110

Halle St. Elisabeth und St. Barbara Krankenhaus, Halle

07747

Jena Universitätsklinikum, Jena

04103

Leipzig UCCL, Leipzig

All Listed Sponsors
lead

University of Erlangen-Nürnberg Medical School

OTHER

NCT01827553 - Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy | Biotech Hunter | Biotech Hunter