Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy
Conditions
Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
pancreatic cancer, chemoradiotherapy, chemotherapy, FOLFIRINOX, gemcitabine
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Induction chemotherapy with gemcitabine or FOLFIRINOX Type: Drug
Name: Radiotherapy, 28 x 1.8 Gy Type: Radiation
Name: Chemotherapy, gemcitabine Type: Drug
Name: Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy Type: Drug
Overall Status
Recruiting
Summary
This randomized trial examines the effectiveness of chemoradiotherapy compared to chemotherapy alone after induction chemotherapy with 3 cycles of gemcitabine or 6 cycles of FOLFIRINOX in patients with locally advanced, non resectable and non-metastatic pancreatic cancer. Chemotherapeutic agent in chemoradiotherapy is gemcitabine administered in 5 cycles, the agent and its administration for sole chemotherapy is determined by induction chemotherapy. Operability of tumor is evaluated at week 11 after randomisation. Patients will be followed for the duration of therapy and for 5 years after the last study treatment. Overall survival at the end of follow up is defined as primary endpoint. Secondary endpoints are tumor-free survival, rate of local recurrence or local progression, rate of distant metastasis, acute and late toxicity of the chemoradiotherapy, quality of life, rate of remission, rate of curative resections (R0) after chemotherapy and chemoradiotherapy. It is planned to include a total number of 830 patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age > 18 years

- histologically confirmed adenocarcinoma of the pancreas

- no evidence of distant metastasis based on computed tomography of the thorax and abdomen

- non resectable pancreatic cancer

- no evidence of peritoneal carcinosis

- ECOG-performance status ≤ 2

- signed study-specific consent form prior to therapy

Exclusion Criteria:

- fertile patients who refuse effective contraception during study treatment

- synchron second malignant neoplasm except basal cell carcinoma of the skin and carcinoma in situ of the cervix after curative therapy

- the Inclusion of patients with prior or concurrent malignancy (≤ 5 years prior to enrolment in study) must be discussed

- chronic inflammatory disease of the intestine

- known allergic reactions on study medication

- on-treatment participation on other trials

- insufficient liver function: Bilirubin > 2,0 mg/dl; SGOT, SGPT, alkaline phosphatase, gGT more than 3 times upper limit of normal (after Stent implantation in case of obstructive jaundice); cirrhosis of the liver Child B and C

- insufficient bone marrow function: WBC < 3,0 x 10^9/l, Platelets > 100 x 10^9/l

- serum creatinine > 1,5 mg/dl, creatinin clearance < 60ml/min (or comparable test)

- preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy, myocardial infarction within the past 6 months, unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) class III or IV heart disease

- neurological and/or psychiatric diseases: stroke, dementia, epilepsy, psychosis

- active intractable or uncontrollable infection, HIV-infection

- prior radiotherapy or chemotherapy
Locations
Aachen Universitätsklinikum
Aachen, Germany
Status: Recruiting
Contact: Ulf Peter Neumann, MD - chirurgie@ukaachen.de
Bayreuth, Klinikum
Bayreuth, Germany
Status: Recruiting
Contact: Ludwig Keilholz, MD - ludwig.keilholz@klinikum-bayreuth.de
Berlin, Charité Universitätsmedizin, Hämatologie/Onkologie
Berlin, Germany
Status: Recruiting
Contact: Marianne Sinn, MD - marianne.sinn@charite.de
Berlin-Lichtenberg, Sana-Klinikum, Hämatologie/Onkologie
Berlin, Germany
Status: Recruiting
Contact: Matthias Federlein, MD - m-federlein@sana-kl.de
Bochum Knappschaftskrankenhaus
Bochum, Germany
Status: Recruiting
Contact: Wolff Schmiegel, MD - meduni-kkh@ruhr-uni-bochum.de
Bochum, Augusta-Kranken-Anstalt, Hämatologie/Onkologie
Bochum, Germany
Status: Recruiting
Contact: Dirk Behringer, MD - behringer@augusta-bochum.de
Bochum, St. Josef-Hospital
Bochum, Germany
Status: Recruiting
Contact: Waldemar Uhl, MD - w.uhl@klinikum-bochum.de
Brandenburg Städtisches Klinikum
Brandenburg, Germany
Status: Recruiting
Contact: René Mantke, MD - mantke@klinikum-brandenburg.de
Bremen Klinikum Mitte
Bremen, Germany
Status: Recruiting
Contact: Johann Ockenga, MD - johann.ockenga@klinikum-bremen-mitte.de
Coburg Klinikum
Coburg, Germany
Status: Recruiting
Contact: Gerhard Grabenbauer, MD - strahlentherapie@diacura.de
Dessau Städtisches Klinikum
Dessau-Roßlau, Germany
Status: Recruiting
Contact: Ilja Ciernik, MD - ilja.ciernik@klinikum-dessau.de
Dresden Onkologische Gemeinschaftspraxis
Dresden, Germany
Status: Recruiting
Contact: Lutz Jacobasch, MD - jacobasch@onkologie-dresden.net
Erlangen Universitätsklinikum
Erlangen, Germany
Status: Recruiting
Contact: Rainer Fietkau, MD - ++49(0) 9131 85 - st-studiensekretariat@uk-erlangen.de
Esslingen Klinikum, Hämatologie/Onkologie
Esslingen, Germany
Status: Recruiting
Contact: Michael Geißler, MD - g.kaiser@klinikum-esslingen.de
Frankfurt/Main Universitätsklinikum
Frankfurt/Main, Germany
Status: Recruiting
Contact: Claus M Rödel, MD - claus.roedel@kgu.de
Frechen PIOH
Frechen, Germany
Status: Recruiting
Contact: Holger Schulz, MD - studiensekretariat@pioh.de
Freiburg Universitätsklinikum
Freiburg, Germany
Status: Recruiting
Contact: Uwe Wittel, MD - uwe.wittel@uniklinik-freiburg.de
Friedrichshafen Onkologische Schwerpunktpraxis
Friedrichshafen, Germany
Status: Recruiting
Contact: Helmut Oettle, MD - helmut.oettle@charite.de
Onkologisches Zentrum Oberland, Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen, Germany
Status: Recruiting
Contact: Helmut Lambertz, MD - helmut.lambertz@klinikum-gap.de
Göppingen Alb-Fils-Kliniken
Göppingen, Germany
Status: Recruiting
Contact: Wolfram Baumann, MD - wolfram.baumann@af-k.de
Göttingen Universitätsmedizin
Göttingen, Germany
Status: Recruiting
Contact: Michael Ghadimi, MD - michael.ghadimi@chirurgie-goettingen.de
Halle St. Elisabeth und St. Barbara Krankenhaus
Halle/Saale, Germany
Status: Recruiting
Contact: Bernhard Opitz, MD - b.opitz@krankenhaus-halle-saale.de
Hamburg Hämatologisch-Onkologischer Schwerpunkt
Hamburg, Germany
Status: Recruiting
Contact: Mathias Bertram, MD - m.bertram@onkologie-partner.de
Heilbronn SLK-Kliniken
Heilbronn, Germany
Status: Recruiting
Contact: Uwe Martens, MD - uwe.martens@slk-kliniken.de
Homburg Universitätsklinikum
Homburg, Germany
Status: Recruiting
Contact: Frank Lammert, MD - frank.lammert@uniklinikum-saarland.de
Jena Universitätsklinikum
Jena, Germany
Status: Recruiting
Contact: Udo Lindig, MD - udo.lindig@med.uni-jena.de
Köln Kliniken
Köln, Germany
Status: Recruiting
Contact: Peter Niehoff, MD - niehoffp@kliniken-koeln.de
Köln Studiengesellschaft
Köln, Germany
Status: Recruiting
Contact: Marcel Reiser, MD - mreiser@pioh.de
Köln Universitätsklinikum
Köln, Germany
Status: Recruiting
Contact: Dirk Waldschmidt, MD - dirk.waldschmidt@uk-koeln.de
Landshut Klinikum
Landshut, Germany
Status: Recruiting
Contact: Barbara Kempf, MD - barbara.kempf@klinikum-landshut.de
Leer MVM
Leer, Germany
Status: Recruiting
Contact: Lothar Müller, MD - lothar.mueller@onkologie-leer.de
Leipzig UCCL
Leipzig, Germany
Status: Recruiting
Contact: Florian Lordick, MD - florian.lordick@medizin.uni-leipzig.de
Leverkusen Klinikum
Leverkusen, Germany
Status: Recruiting
Contact: Astrid Charles, MD - astrid.charles@klinikum-lev.de
Magdeburg Klinikum
Magdeburg, Germany
Status: Recruiting
Contact: Karsten Ridwelski, MD - karsten.ridwelski@klinikum-magdeburg.de
Magdeburg Universitätsklinikum
Magdeburg, Germany
Status: Recruiting
Contact: Benjamin Garlipp, MD - benjamin.garlipp@med.ovgu.de
Mainz Universitätsmedizin
Mainz, Germany
Status: Recruiting
Contact: Heinz Schmidberger, MD - heinz.schmidberger@unimedizin-mainz.de
Mannheim Universitätsmedizin
Mannheim, Germany
Status: Recruiting
Contact: Nicolai Härtel, MD - nicolai.haertel@umm.de
Marburg Universitätsklinikum
Marburg, Germany
Status: Recruiting
Contact: Nina Wandel, MD - wandeln@med.uni-marburg.de
München Großhadern LMU
München, Germany
Status: Recruiting
Contact: Volker Heinemann, MD - volker.heinemann@med.uni-muenchen.de
Münster Universitätsklinikum
Münster, Germany
Status: Recruiting
Contact: Hans Th. Eich, MD - Hans.Eich@ukmuenster.de
Oldenburg Pius Hospital
Oldenburg, Germany
Status: Recruiting
Contact: Frank Griesinger, MD - frank.griesinger@pius-hospital.de
Ostfildern Paracelsus Krankenhaus Ruit
Ostfildern, Germany
Status: Recruiting
Contact: Matthias Geiger, MD - m.geiger@kk-es.de
Regensburg Krankenhaus Barmherzige Brüder
Regensburg, Germany
Status: Recruiting
Contact: Nicolas Moosmann, MD - nicolas.moosmann@barmherzige-regensburg.de
Regensburg Universitätsklinikum
Regensburg, Germany
Status: Recruiting
Contact: Matthias Hautmann, MD - matthias.hautmann@klinik.uni-regensburg.de
Stuttgart Klinikum SCC
Stuttgart, Germany
Status: Recruiting
Contact: Gerald Illerhaus, MD - g.illerhaus@klinikum-stuttgart.de
Stuttgart Marienhospital
Stuttgart, Germany
Status: Recruiting
Contact: Claudio Denzlinger, MD - inn3@vinzenz.de
Traunstein Klinikum
Traunstein, Germany
Status: Recruiting
Contact: Thomas W. Kubin, MD - thomas.kubin@klinikum-traunstein.de
Trier Krankenhaus der Barmherzigen Brüder
Trier, Germany
Status: Recruiting
Contact: Heinz Kirchen, MD - h.kirchen@bk-trier.de
Trier Mutterhaus der Borromäerinnen
Trier, Germany
Status: Recruiting
Contact: Rolf Mahlberg, MD - mahlberg@mutterhaus.de
Tübingen Universitätsklinikum
Tübingen, Germany
Status: Recruiting
Contact: Michael Bitzer, MD - michael.bitzer@med.uni-tuebingen.de
Ulm Universitätsklinikum
Ulm, Germany
Status: Recruiting
Contact: Thomas Seufferlein, MD - thomas.seufferlein@uniklinik-ulm.de
Würzburg CCC Mainfranken
Würzburg, Germany
Status: Recruiting
Contact: Volker Kunzmann, MD - kunzmann_v@klinik.uni-wuerzburg.de
Start Date
March 2013
Completion Date
April 2022
Sponsors
University of Erlangen-Nürnberg Medical School
Source
University of Erlangen-Nürnberg Medical School
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page