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

April 10, 2024 updated by: University of Erlangen-Nürnberg Medical School

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

830

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bayreuth, Germany, 95445
        • Bayreuth, Klinikum
      • Bochum, Germany, 44791
        • Bochum, Augusta-Kranken-Anstalt, Hämatologie/Onkologie
      • Bochum, Germany, 44791
        • Bochum, St. Josef-Hospital
      • Dresden, Germany, 01307
        • Dresden Onkologische Gemeinschaftspraxis
      • Erlangen, Germany, 91054
        • Erlangen Universitätsklinikum
      • Frankfurt/Main, Germany, 60590
        • Frankfurt/Main Universitätsklinikum
      • Freiburg, Germany, 79106
        • Freiburg Universitätsklinikum
      • Göttingen, Germany, 37075
        • Göttingen Universitätsmedizin
      • Halle/Saale, Germany, 06110
        • Halle St. Elisabeth und St. Barbara Krankenhaus
      • Heilbronn, Germany, 74078
        • Heilbronn SLK-Kliniken
      • Jena, Germany, 07747
        • Jena Universitätsklinikum
      • Köln, Germany, 50937
        • Köln Universitätsklinikum
      • Leer, Germany, 26789
        • Leer MVM
      • Leipzig, Germany, 04103
        • Leipzig UCCL
      • Magdeburg, Germany, 39120
        • Magdeburg Universitätsklinikum
      • Magdeburg, Germany, 39130
        • Magdeburg Klinikum
      • Mannheim, Germany, 68167
        • Mannheim Universitätsmedizin
      • München, Germany, 81377
        • München Großhadern LMU
      • Münster, Germany, 48149
        • Münster Universitätsklinikum
      • Oldenburg, Germany, 26121
        • Oldenburg Pius Hospital
      • Regensburg, Germany, 93049
        • Regensburg Krankenhaus Barmherzige Brüder
      • Regensburg, Germany, 93053
        • Regensburg Universitätsklinikum
      • Würzburg, Germany, 97080
        • Würzburg CCC Mainfranken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • all brands of gemcitabine and FOLFIRINOX components are allowed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Participants will be followed for the duration of therapy and for 5 years after the last study treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumor-free survival
Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Participants will be followed for the duration of therapy and for 5 years after the last study treatment
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
Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Rate of distant metastasis
Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Participants will be followed for the duration of therapy and for 5 years after the last study treatment
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
Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Rate of remission
Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Participants will be followed for the duration of therapy and for 5 years after the last study treatment
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
Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Changes in Quality of life
Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Participants will be followed for the duration of therapy and for 5 years after the last study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Investigators

  • Principal Investigator: Rainer Fietkau, MD, Strahlenklinik, Universitätsklinikum Erlangen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2013

Primary Completion (Actual)

February 2, 2021

Study Completion (Actual)

November 8, 2023

Study Registration Dates

First Submitted

April 4, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimated)

April 9, 2013

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-014476-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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