Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy
CONKO-007
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
1 other identifier
interventional
830
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pancreatic-cancer
Started Apr 2013
Longer than P75 for phase_3 pancreatic-cancer
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2013
CompletedStudy Start
First participant enrolled
April 4, 2013
CompletedFirst Posted
Study publicly available on registry
April 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2023
CompletedApril 11, 2024
August 1, 2023
7.8 years
April 4, 2013
April 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Secondary Outcomes (7)
Tumor-free survival
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
Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Rate of distant metastasis
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
Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Rate of remission
Participants will be followed for the duration of therapy and for 5 years after the last study treatment
- +2 more secondary outcomes
Study Arms (2)
Induction CT, chemoradiotherapy
EXPERIMENTALInduction chemotherapy with gemcitabine or FOLFIRINOX; Radiotherapy, 28 x 1.8 Gy; Chemotherapy, gemcitabine;
Induction CT, chemotherapy
ACTIVE COMPARATORInduction chemotherapy with gemcitabine or FOLFIRINOX; Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy
Interventions
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)
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.
5 cycles of 300 mg/m\^2/d gemcitabine infusions and than 3 administrations of 1000 mg/m\^2/d
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Bayreuth, Klinikum
Bayreuth, 95445, Germany
Bochum, Augusta-Kranken-Anstalt, Hämatologie/Onkologie
Bochum, 44791, Germany
Bochum, St. Josef-Hospital
Bochum, 44791, Germany
Köln Universitätsklinikum
Cologne, 50937, Germany
Dresden Onkologische Gemeinschaftspraxis
Dresden, 01307, Germany
Erlangen Universitätsklinikum
Erlangen, 91054, Germany
Frankfurt/Main Universitätsklinikum
Frankfurt am Main, 60590, Germany
Freiburg Universitätsklinikum
Freiburg im Breisgau, 79106, Germany
Göttingen Universitätsmedizin
Göttingen, 37075, Germany
Halle St. Elisabeth und St. Barbara Krankenhaus
Halle, 06110, Germany
Heilbronn SLK-Kliniken
Heilbronn, 74078, Germany
Jena Universitätsklinikum
Jena, 07747, Germany
Leer MVM
Leer, 26789, Germany
Leipzig UCCL
Leipzig, 04103, Germany
Magdeburg Universitätsklinikum
Magdeburg, 39120, Germany
Magdeburg Klinikum
Magdeburg, 39130, Germany
Mannheim Universitätsmedizin
Mannheim, 68167, Germany
München Großhadern LMU
München, 81377, Germany
Münster Universitätsklinikum
Münster, 48149, Germany
Oldenburg Pius Hospital
Oldenburg, 26121, Germany
Regensburg Krankenhaus Barmherzige Brüder
Regensburg, 93049, Germany
Regensburg Universitätsklinikum
Regensburg, 93053, Germany
Würzburg CCC Mainfranken
Würzburg, 97080, Germany
Related Publications (2)
Fietkau R, Ghadimi M, Grutzmann R, Wittel UA, Jacobasch L, Uhl W, Croner RS, Bechstein WO, Neumann UP, Waldschmidt D, Boeck S, Moosmann N, Reinacher-Schick AC, Golcher H, Adler W, Semrau S, Lubgan D, Kallies A, Hecht M, Tischoff I, Tannapfel A, Frey B, Oettle H; CONKO Study Group. Benefit of Chemoradiotherapy Versus Chemotherapy After Induction Therapy for Conversion of Unresectable Into Resectable Pancreatic Cancer: The Randomized CONKO-007 Trial. J Clin Oncol. 2025 Oct 20;43(30):3266-3278. doi: 10.1200/JCO-24-01502. Epub 2025 Aug 13.
PMID: 40802908DERIVEDWittel UA, Lubgan D, Ghadimi M, Belyaev O, Uhl W, Bechstein WO, Grutzmann R, Hohenberger WM, Schmid A, Jacobasch L, Croner RS, Reinacher-Schick A, Hopt UT, Pirkl A, Oettle H, Fietkau R, Golcher H. Consensus in determining the resectability of locally progressed pancreatic ductal adenocarcinoma - results of the Conko-007 multicenter trial. BMC Cancer. 2019 Oct 22;19(1):979. doi: 10.1186/s12885-019-6148-5.
PMID: 31640628DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rainer Fietkau, MD
Strahlenklinik, Universitätsklinikum Erlangen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2013
First Posted
April 9, 2013
Study Start
April 4, 2013
Primary Completion
February 2, 2021
Study Completion
November 8, 2023
Last Updated
April 11, 2024
Record last verified: 2023-08