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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction CT, chemoradiotherapy | Experimental | Induction chemotherapy with gemcitabine or FOLFIRINOX; Radiotherapy, 28 x 1.8 Gy; Chemotherapy, gemcitabine; |
|
| Induction CT, chemotherapy | Active Comparator | Induction chemotherapy with gemcitabine or FOLFIRINOX; Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction chemotherapy with gemcitabine or FOLFIRINOX | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Participants will be followed for the duration of therapy and for 5 years after the last study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rainer Fietkau, MD | Strahlenklinik, Universitätsklinikum Erlangen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bayreuth, Klinikum | Bayreuth | 95445 | Germany | |||
| Bochum, Augusta-Kranken-Anstalt, Hämatologie/Onkologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40802908 | Derived | 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. | |
| 31640628 |
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|
|
| Radiotherapy, 28 x 1.8 Gy | Radiation | 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. |
|
| Chemotherapy, gemcitabine | Drug | 5 cycles of 300 mg/m^2/d gemcitabine infusions and than 3 administrations of 1000 mg/m^2/d |
|
|
| Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy | Drug | 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 |
|
|
| 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 |
| Rate of curative resections (R0) after chemotherapy and chemoradiotherapy | Participants will be followed for the duration of therapy and for 5 years after the last study treatment |
| Changes in Quality of life | Participants will be followed for the duration of therapy and for 5 years after the last study treatment |
| 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 |
| Derived |
| Wittel 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. |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D060828 | Induction Chemotherapy |
| D000093542 | Gemcitabine |
| C000627770 | folfirinox |
| D011878 | Radiotherapy |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012074 | Remission Induction |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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