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Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy (CONKO-007)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01827553
Recruitment Status : Recruiting
First Posted : April 9, 2013
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Induction chemotherapy with gemcitabine or FOLFIRINOX Radiation: Radiotherapy, 28 x 1.8 Gy Drug: Chemotherapy, gemcitabine Drug: Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 830 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Significance of Chemoradiation Following Induction Chemotherapy in Locally Advanced,Unresectable Pancreatic Cancer -a Randomised Phase 3 Trial: Chemoradiation Following Induction Chemotherapy Compared With Chemotherapy Alone
Study Start Date : March 2013
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Induction CT, chemoradiotherapy
Induction chemotherapy with gemcitabine or FOLFIRINOX; Radiotherapy, 28 x 1.8 Gy; Chemotherapy, gemcitabine;
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)
Other Name: all brands of gemcitabine and FOLFIRINOX components are allowed

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
Other Name: all brands of gemcitabine are allowed

Active Comparator: Induction CT, chemotherapy
Induction chemotherapy with gemcitabine or FOLFIRINOX; Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy
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)
Other Name: all brands of gemcitabine and FOLFIRINOX components are allowed

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
Other Name: all brands of gemcitabine and FOLFIRINOX components are allowed




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ]

Secondary Outcome Measures :
  1. Tumor-free survival [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ]
  2. rate of local recurrence or local progression [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ]
  3. Rate of distant metastasis [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ]
  4. Acute and late toxicity of the chemoradiotherapy [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ]
  5. Quality of life [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ]
  6. Rate of remission [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ]
  7. Rate of curative resections (R0) after chemotherapy and chemoradiotherapy [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827553


Contacts
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Contact: Rainer Fietkau, MD ++49(0)9131 85 ext 33968 st-studiensekretariat@uk-erlangen.de
Contact: Sabine Semrau, MD ++49(0)9131 85 ext 33968 st-studiensekretariat@uk-erlangen.de

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Locations
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Germany
Aachen Universitätsklinikum Recruiting
Aachen, Germany, 52074
Contact: Ulf Peter Neumann, MD       chirurgie@ukaachen.de   
Contact: Florian Ulmer, MD       fulmer@ukaachen.de   
Principal Investigator: Ulf Peter Neumann, MD         
Sub-Investigator: Florian Ulmer, MD         
Bayreuth, Klinikum Recruiting
Bayreuth, Germany, 95445
Contact: Ludwig Keilholz, MD       ludwig.keilholz@klinikum-bayreuth.de   
Contact: Alexander Kiani, MD       alexander.kiani@klinikum-bayreuth.de   
Principal Investigator: Ludwig Keilholz, MD         
Sub-Investigator: Alexander Kiani, MD         
Berlin-Lichtenberg, Sana-Klinikum, Hämatologie/Onkologie Terminated
Berlin, Germany, 10365
Berlin, Charité Universitätsmedizin, Hämatologie/Onkologie Recruiting
Berlin, Germany, 13353
Contact: Marianne Sinn, MD       marianne.sinn@charite.de   
Contact: Uwe Pelzer, MD       uwe.pelzer@charite.de   
Principal Investigator: Marianne Sinn, MD         
Sub-Investigator: Uwe Pelzer, MD         
Bochum, Augusta-Kranken-Anstalt, Hämatologie/Onkologie Recruiting
Bochum, Germany, 44791
Contact: Dirk Behringer, MD       behringer@augusta-bochum.de   
Contact: Michael Brandt       brandt@augusta-bochum.de   
Principal Investigator: Dirk Behringer, MD         
Sub-Investigator: Michael Brandt         
Bochum, St. Josef-Hospital Recruiting
Bochum, Germany, 44791
Contact: Waldemar Uhl, MD       w.uhl@klinikum-bochum.de   
Contact: Peter R Ritter, MD       anke.reinacher@rub.de   
Principal Investigator: Waldemar Uhl, MD         
Sub-Investigator: Anke Reinacher-Schick, MD         
Bochum Knappschaftskrankenhaus Recruiting
Bochum, Germany, 44892
Contact: Wolff Schmiegel, MD       meduni-kkh@ruhr-uni-bochum.de   
Contact: Michael Pohl, MD       michael.pohl-4@rub.de   
Principal Investigator: Wolff Schmiegel, MD         
Sub-Investigator: Michael Pohl, MD         
Brandenburg Städtisches Klinikum Recruiting
Brandenburg, Germany, 14770
Contact: René Mantke, MD       mantke@klinikum-brandenburg.de   
Contact: Peter Markus Deckert, Deckert       deckert@klinikum-brandenburg.de   
Principal Investigator: René Mantke, MD         
Sub-Investigator: Peter Markus Deckert, MD         
Bremen Klinikum Mitte Recruiting
Bremen, Germany, 28177
Contact: Johann Ockenga, MD       johann.ockenga@klinikum-bremen-mitte.de   
Contact: Thomas Martin, MD       thomas.martin@klinikum-bremen-mitte.de   
Principal Investigator: Johann Ockenga, MD         
Sub-Investigator: Thomas Martin, MD         
Coburg Klinikum Terminated
Coburg, Germany, 96450
Dessau Städtisches Klinikum Withdrawn
Dessau, Germany, 06847
Dresden Onkologische Gemeinschaftspraxis Recruiting
Dresden, Germany, 01307
Contact: Lutz Jacobasch, MD       jacobasch@onkologie-dresden.net   
Contact: Thomas Wolf, MD       wolf@onkologie-dresden.net   
Principal Investigator: Lutz Jacobasch, MD         
Sub-Investigator: Thomas Wolf, MD         
Erlangen Universitätsklinikum Recruiting
Erlangen, Germany, 91054
Contact: Rainer Fietkau, MD    ++49(0) 9131 85 ext 33968    st-studiensekretariat@uk-erlangen.de   
Contact: Sabine Semrau, MD    ++49(0) 9131 85 ext 33968    st-studiensekretariat@uk-erlangen.de   
Principal Investigator: Rainer Fietkau, MD         
Sub-Investigator: Sabine Semrau, MD         
Esslingen Klinikum, Hämatologie/Onkologie Recruiting
Esslingen, Germany, 73730
Contact: Michael Geißler, MD       g.kaiser@klinikum-esslingen.de   
Contact: Sven Weßendorf, MD         
Principal Investigator: Michael Geißler, MD         
Sub-Investigator: Carsten Schwänen, MD         
Frankfurt/Main Universitätsklinikum Recruiting
Frankfurt/Main, Germany, 60590
Contact: Claus M Rödel, MD       claus.roedel@kgu.de   
Contact: Detlef Imhoff, MD       strahlentherapie@kgu.de   
Principal Investigator: Claus M Rödel, MD         
Sub-Investigator: Detlef Imhoff, MD         
Frechen PIOH Withdrawn
Frechen, Germany, 50226
Freiburg Universitätsklinikum Recruiting
Freiburg, Germany, 79106
Contact: Uwe Wittel, MD       uwe.wittel@uniklinik-freiburg.de   
Contact: Ulrich T Hopt, MD       ulrich.hopt@uniklinik-freiburg.de   
Principal Investigator: Uwe Wittel, MD         
Sub-Investigator: Ulrich T Hopt, MD         
Friedrichshafen Onkologische Schwerpunktpraxis Recruiting
Friedrichshafen, Germany, 88045
Contact: Helmut Oettle, MD       helmut.oettle@charite.de   
Contact: Frank Mayer, MD       frank.mayer@med.uni-tuebingen.de   
Principal Investigator: Helmut Oettle, MD         
Sub-Investigator: Frank Mayer, MD         
Onkologisches Zentrum Oberland, Klinikum Garmisch-Partenkirchen Terminated
Garmisch-Partenkirchen, Germany, 82467
Göppingen Alb-Fils-Kliniken Withdrawn
Göppingen, Germany, 73035
Göttingen Universitätsmedizin Recruiting
Göttingen, Germany, 37075
Contact: Michael Ghadimi, MD       michael.ghadimi@chirurgie-goettingen.de   
Contact: Hendrik Wolff, MD       hendrik.wolff@med.uni-goettingen.de   
Principal Investigator: Michael Ghadimi, MD         
Sub-Investigator: Hendrik Wolff, MD         
Halle St. Elisabeth und St. Barbara Krankenhaus Recruiting
Halle/Saale, Germany, 06110
Contact: Bernhard Opitz, MD       b.opitz@krankenhaus-halle-saale.de   
Contact: Judith Böhme, MD       j.boehme@krankenhaus-halle-saale.de   
Sub-Investigator: Bernhard Opitz, MD         
Sub-Investigator: Judith Böhme, MD         
Hamburg Hämatologisch-Onkologischer Schwerpunkt Recruiting
Hamburg, Germany, 22457
Contact: Mathias Bertram, MD       m.bertram@onkologie-partner.de   
Contact: Sigrun Müller-Hagen, MD       s.mueller-hagen@onkologie-partner.de   
Principal Investigator: Mathias Bertram, MD         
Sub-Investigator: Sigrun Müller-Hagen, MD         
Heilbronn SLK-Kliniken Recruiting
Heilbronn, Germany, 74078
Contact: Uwe Martens, MD       uwe.martens@slk-kliniken.de   
Contact: Markus Lindauer, MD       markus.lindauer@slk-kliniken.de   
Principal Investigator: Uwe Martens, MD         
Sub-Investigator: Markus Lindauer, MD         
St. Bernward Krankenhaus GmbH Not yet recruiting
Hildesheim, Germany, 31134
Contact: Ulrich Kaiser, Prof.    +49 5121 90 ext 1274    prof.dr.u.kaiser@bernward-khs.de   
Contact: Thomas Heide, M.D.    +49 512190 ext 1433    dr.t.heide@bernward-khs.de   
Homburg Universitätsklinikum Terminated
Homburg, Germany, 66421
Jena Universitätsklinikum Recruiting
Jena, Germany, 07747
Contact: Udo Lindig, MD       udo.lindig@med.uni-jena.de   
Contact: Ekkehard Eigendorff, MD       ekkehard.eigendorff@med.uni-jena.de   
Principal Investigator: Udo Lindig, MD         
Sub-Investigator: Ekkehard Eigendorff, MD         
Köln Studiengesellschaft Withdrawn
Köln, Germany, 50674
Köln Universitätsklinikum Recruiting
Köln, Germany, 50937
Contact: Dirk Waldschmidt, MD       dirk.waldschmidt@uk-koeln.de   
Contact: Arnulf H Hölscher, MD       Arnulf.Hoelscher@uk-koeln.de   
Principal Investigator: Dirk Waldschmidt, MD         
Sub-Investigator: Arnulf H Hölscher, MD         
Köln Kliniken Terminated
Köln, Germany, 51109
Landshut Klinikum Withdrawn
Landshut, Germany, 84034
Leer MVM Recruiting
Leer, Germany, 26789
Contact: Lothar Müller, MD       lothar.mueller@onkologie-leer.de   
Contact: Carsten Janßen, MD       carsten.janssen@onkologie-leer.de   
Principal Investigator: Lothar Müller, MD         
Sub-Investigator: Carsten Janßen, MD         
Leipzig UCCL Recruiting
Leipzig, Germany, 04103
Contact: Florian Lordick, MD       florian.lordick@medizin.uni-leipzig.de   
Contact: Gertraud Stocker, MD       gertraud.stocker@medizin.uni-leipzig.de   
Principal Investigator: Florian Lordick, MD         
Sub-Investigator: Gertraud Stocker, MD         
Leverkusen Klinikum Recruiting
Leverkusen, Germany, 51375
Contact: Astrid Charles, MD       astrid.charles@klinikum-lev.de   
Contact: Stephanie Hammans, MD       stephanie.hammans@klinikum-lev.de   
Principal Investigator: Astrid Charles, MD         
Sub-Investigator: Stephanie Hammans, MD         
Magdeburg Universitätsklinikum Recruiting
Magdeburg, Germany, 39120
Contact: Benjamin Garlipp, MD       benjamin.garlipp@med.ovgu.de   
Contact: Kerstin Schütte, MD       kerstin.schuette@med.ovgu.de   
Principal Investigator: Benjamin Garlipp, MD         
Sub-Investigator: Kerstin Schütte, MD         
Magdeburg Klinikum Recruiting
Magdeburg, Germany, 39130
Contact: Karsten Ridwelski, MD       karsten.ridwelski@klinikum-magdeburg.de   
Contact: Christoph Kahl, MD       christoph.kahl@klinikum-magdeburg.de   
Principal Investigator: Karsten Ridwelski, MD         
Sub-Investigator: Christoph Kahl, MD         
Mainz Universitätsmedizin Terminated
Mainz, Germany, 55131
Mannheim Universitätsmedizin Recruiting
Mannheim, Germany, 68167
Contact: Nicolai Härtel, MD       nicolai.haertel@umm.de   
Contact: Nadine Schulte, MD       nadine.schulte@umm.de   
Principal Investigator: Nicolai Härtel, MD         
Sub-Investigator: Nadine Schulte, MD         
Marburg Universitätsklinikum Terminated
Marburg, Germany, 35043
München Großhadern LMU Recruiting
München, Germany, 81377
Contact: Volker Heinemann, MD       volker.heinemann@med.uni-muenchen.de   
Contact: Stefan Böck, MD       sekrmed3@med.uni-muenchen.de   
Principal Investigator: Volker Heinemann, MD         
Sub-Investigator: Stefan Böck, MD         
Münster Universitätsklinikum Recruiting
Münster, Germany, 48149
Contact: Hans Th. Eich, MD       Hans.Eich@ukmuenster.de   
Contact: Christoph Anthoni, MD       christoph.anthoni@ukmuenster.de   
Principal Investigator: Hans Th. Eich, MD         
Sub-Investigator: Christoph Anthoni, MD         
Oldenburg Pius Hospital Recruiting
Oldenburg, Germany, 26121
Contact: Frank Griesinger, MD       frank.griesinger@pius-hospital.de   
Contact: Hagen Flach, MD       hagen.flach@pius-hospital.de   
Principal Investigator: Frank Griesinger, MD         
Sub-Investigator: Hagen Flach, MD         
Ostfildern Paracelsus Krankenhaus Ruit Terminated
Ostfildern, Germany, 73760
Regensburg Krankenhaus Barmherzige Brüder Recruiting
Regensburg, Germany, 93049
Contact: Nicolas Moosmann, MD       nicolas.moosmann@barmherzige-regensburg.de   
Contact: Anke Schlenska-Lange, MD       anke.schlenska-lange@barmherzige-regensburg.de   
Principal Investigator: Nicolas Moosmann, MD         
Sub-Investigator: Anke Schlenska-Lange, MD         
Regensburg Universitätsklinikum Recruiting
Regensburg, Germany, 93053
Contact: Matthias Hautmann, MD       matthias.hautmann@klinik.uni-regensburg.de   
Contact: Oliver Koelbl, MD       oliver.koelbl@ukr.de   
Principal Investigator: Matthias Hautmann, MD         
Sub-Investigator: Oliver Koelbl, MD         
Stuttgart Klinikum SCC Recruiting
Stuttgart, Germany, 70174
Contact: Gerald Illerhaus, MD       g.illerhaus@klinikum-stuttgart.de   
Contact: Alberta-May Daraban, MD       a.daraban@klinikum-stuttgart.de   
Principal Investigator: Gerald Illerhaus, MD         
Sub-Investigator: Alberta-May Daraban, MD         
Stuttgart Marienhospital Terminated
Stuttgart, Germany, 70199
Traunstein Klinikum Recruiting
Traunstein, Germany, 83278
Contact: Thomas W. Kubin, MD       thomas.kubin@klinikum-traunstein.de   
Contact: Elke Hagenreiner, MD       elke.hagenreiner@klinikum-traunstein.de   
Principal Investigator: Thomas W. Kubin, MD         
Sub-Investigator: Elke Hagenreiner, MD         
Trier Mutterhaus der Borromäerinnen Withdrawn
Trier, Germany, 54290
Trier Krankenhaus der Barmherzigen Brüder Terminated
Trier, Germany, 54292
Tübingen Universitätsklinikum Terminated
Tübingen, Germany, 72076
Ulm Universitätsklinikum Terminated
Ulm, Germany, 89081
Würzburg CCC Mainfranken Recruiting
Würzburg, Germany, 97080
Contact: Volker Kunzmann, MD       kunzmann_v@klinik.uni-wuerzburg.de   
Contact: Michaela Metz, MD       metz_m2@klinik.uni-wuerzburg.de   
Principal Investigator: Volker Kunzmann, MD         
Sub-Investigator: Michaela Metz, MD         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Rainer Fietkau, MD Strahlenklinik, Universitätsklinikum Erlangen

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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01827553     History of Changes
Other Study ID Numbers: 2009-014476-21
First Posted: April 9, 2013    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Keywords provided by University of Erlangen-Nürnberg Medical School:
pancreatic cancer
chemoradiotherapy
chemotherapy
FOLFIRINOX
gemcitabine
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs