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

This study is currently recruiting participants.
Verified April 2013 by University of Erlangen-Nürnberg Medical School
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01827553
First received: April 4, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  Purpose

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 four weeks after end of treatment. 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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor-free survival [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Rate of distant metastasis [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ] [ Designated as safety issue: No ]
  • Rate of remission [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 830
Study Start Date: March 2013
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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: 2 cycles a 3 administrations of 300 mg/m^2/d gemcitabine infusions FOLFIRINOX: 4 cycles
Other Name: all brands of gemcitabine and FOLFIRINOX components are allowed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01827553

Contacts
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

Locations
Germany
Aachen Universitätsklinikum Recruiting
Aachen, Germany, 52074
Contact: Ulf Peter Neumann, MD       chirurgie@ukaachen.de   
Contact: Karsten Junge, MD       kjunge@ukaachen.de   
Principal Investigator: Ulf Peter Neumann, MD         
Sub-Investigator: Karsten Junge, MD         
Augsburg Klinikum, III. Medizinische Klinik Recruiting
Augsburg, Germany, 86156
Contact: Helmut Messmann, MD       helmut.messmann@klinikum-augsburg.de   
Contact: Andreas Probst, MD       andreas.probst@klinikum-augsburg.de   
Principal Investigator: Helmut Messmann, MD         
Sub-Investigator: Andreas Probst, 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, 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         
Berlin-Lichtenberg, Sana-Klinikum, Hämatologie/Onkologie Recruiting
Berlin, Germany, 10365
Contact: Yüksel Atas, MD       y.atas@sana-kl.de   
Contact: Christoph Schmöcker, MD       c.schmoecker@sana-kl.de   
Principal Investigator: Yüksel Atas         
Sub-Investigator: Christoph Schmöcker, 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       peter.r.ritter@ruhr-uni-bochum.de   
Principal Investigator: Waldemar Uhl, MD         
Sub-Investigator: Peter R Ritter, 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         
Coburg Klinikum Recruiting
Coburg, Germany, 96450
Contact: Gerhard Grabenbauer, MD       strahlentherapie@diacura.de   
Contact: Christof Lamberti, MD       christof.lamberti@klinikum-coburg.de   
Principal Investigator: Gerhard Grabenbauer, MD         
Sub-Investigator: Christof Lamberti, MD         
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 Active, not recruiting
Esslingen, Germany, 73730
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         
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 Recruiting
Garmisch-Partenkirchen, Germany, 82467
Contact: Helmut Lambertz, MD       helmut.lambertz@klinikum-gap.de   
Contact: Daniel Weber       daniel.weber@klinikum-gap.de   
Principal Investigator: Helmut Lambertz, MD         
Sub-Investigator: Daniel Weber         
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         
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         
Homburg Universitätsklinikum Recruiting
Homburg, Germany, 66421
Contact: Frank Lammert, MD         
Contact: Simone Zimmermann, MD       simone.zimmmermann@uks.eu   
Principal Investigator: Frank Lammert, MD         
Sub-Investigator: Simone Zimmermann, MD         
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 Universitätsklinikum Not yet 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 Recruiting
Köln, Germany, 51109
Contact: Peter Niehoff, MD       niehoffp@kliniken-koeln.de   
Contact: Birgitta Bungart, MD       bungart@kliniken-koeln.de   
Principal Investigator: Peter Niehoff, MD         
Sub-Investigator: Birgitta Bungart, 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         
Magdeburg Universitätsklinikum Recruiting
Magdeburg, Germany, 39120
Contact: Patrick Stübs, MD       patrick.stuebs@med.ovgu.de   
Contact: Benjamin Garlipp, MD       benjamin.garlipp@med.ovgu.de   
Principal Investigator: Patrick Stübs, MD         
Sub-Investigator: Benjamin Garlipp, MD         
Mainz Universitätsmedizin Not yet recruiting
Mainz, Germany, 55131
Contact: Heinz Schmidberger, MD       heinz.schmidberger@unimedizin-mainz.de   
Contact: Silla Hey-Koch, MD       silla.hey-koch@unimedizin-mainz.de   
Principal Investigator: Heinz Schmidberger, MD         
Sub-Investigator: Silla Hey-Koch, MD         
Marburg Universitätsklinikum Recruiting
Marburg, Germany, 35043
Contact: Patrick Michl, MD       michlp@med.uni-marburg.de   
Contact: Sebastian Krug, MD       krugs@med.uni-marburg.de   
Principal Investigator: Patrick Michl, MD         
Sub-Investigator: Sebastian Krug, MD         
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: Christoph Anthoni, MD       christoph.anthoni@ukmuenster.de   
Contact: Daniel Palmes, MD       palmes@uni-muenster.de   
Principal Investigator: Christoph Anthoni, MD         
Sub-Investigator: Daniel Palmes, MD         
Ostfildern Paracelsus Krankenhaus Ruit Recruiting
Ostfildern, Germany, 73760
Contact: Matthias Geiger, MD       m.geiger@kk-es.de   
Contact: Nicole Morell, MD       n.morell@kk-es.de   
Principal Investigator: Matthias Geiger, MD         
Sub-Investigator: Nicole Morell, MD         
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         
Stuttgart Marienhospital Recruiting
Stuttgart, Germany, 70199
Contact: Claudio Denzlinger, MD       inn3@vinzenz.de   
Contact: Mona Rohm       monarohm@vinzenz.de   
Principal Investigator: Claudio Denzlinger, MD         
Sub-Investigator: Mona Rohm, MD         
Trier Krankenhaus der Barmherzigen Brüder Recruiting
Trier, Germany, 54292
Contact: Heinz Kirchen, MD       h.kirchen@bk-trier.de   
Contact: Monika Lankeshofer-Loch       m.lankeshofer-loch@bk-trier.de   
Principal Investigator: Heinz Kirchen, MD         
Sub-Investigator: Monika Lankeshofer-Loch         
Tübingen Universitätsklinikum Recruiting
Tübingen, Germany, 72076
Contact: Michael Bitzer, MD       michael.bitzer@med.uni-tuebingen.de   
Contact: Ruben Plentz, MD       Ruben.plentz@med.uni-tuebingen.de   
Principal Investigator: Michael Bitzer, MD         
Sub-Investigator: Ruben Plentz, MD         
Würzburg CCC Mainfranken Recruiting
Würzburg, Germany, 97080
Contact: Matthias Guckenberger, MD       guckenberg_m@klinik.uni-wuerzburg.de   
Contact: Volker Kunzmann, MD       kunzmann_v@klinik.uni-wuerzburg.de   
Principal Investigator: Matthias Guckenberger, MD         
Sub-Investigator: Volker Kunzmann, MD         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Rainer Fietkau, MD Strahlenklinik, Universitätsklinikum Erlangen
  More Information

No publications provided

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01827553     History of Changes
Other Study ID Numbers: 2009-014476-21
Study First Received: April 4, 2013
Last Updated: April 4, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Erlangen-Nürnberg Medical School:
pancreatic cancer
chemoradiotherapy
chemotherapy
FOLFIRINOX
gemcitabine

Additional relevant MeSH terms:
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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 17, 2014