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Pancreatic CancerPhase 3CONKO-007NCT01827553

Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy

A Phase 3 study testing Induction chemotherapy with gemcitabine or FOLFIRINOX, Radiotherapy, 28 x 1.8 Gy and Chemotherapy, gemcitabine in people with Pancreatic Cancer, run by University of Erlangen-Nürnberg Medical School at 23 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Induction chemotherapy with gemcitabine or FOLFIRINOX, Radiotherapy, 28 x 1.8 Gy and Chemotherapy, gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
830 participants
Where
23 sitesGermany
Study dates
4 Apr 2013to 8 Nov 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Germany23 sites

  • Bayreuth, Klinikum

    Bayreuth, 95445

  • Bochum, Augusta-Kranken-Anstalt, Hämatologie/Onkologie

    Bochum, 44791

  • Bochum, St. Josef-Hospital

    Bochum, 44791

  • Köln Universitätsklinikum

    Cologne, 50937

  • Dresden Onkologische Gemeinschaftspraxis

    Dresden, 01307

  • Erlangen Universitätsklinikum

    Erlangen, 91054

  • Frankfurt/Main Universitätsklinikum

    Frankfurt am Main, 60590

  • Freiburg Universitätsklinikum

    Freiburg im Breisgau, 79106

  • Göttingen Universitätsmedizin

    Göttingen, 37075

  • Halle St. Elisabeth und St. Barbara Krankenhaus

    Halle, 06110

  • Heilbronn SLK-Kliniken

    Heilbronn, 74078

  • Jena Universitätsklinikum

    Jena, 07747

  • Leer MVM

    Leer, 26789

  • Leipzig UCCL

    Leipzig, 04103

  • Magdeburg Universitätsklinikum

    Magdeburg, 39120

  • Magdeburg Klinikum

    Magdeburg, 39130

  • Mannheim Universitätsmedizin

    Mannheim, 68167

  • München Großhadern LMU

    München, 81377

  • Münster Universitätsklinikum

    Münster, 48149

  • Oldenburg Pius Hospital

    Oldenburg, 26121

  • Regensburg Krankenhaus Barmherzige Brüder

    Regensburg, 93049

  • Regensburg Universitätsklinikum

    Regensburg, 93053

  • Würzburg CCC Mainfranken

    Würzburg, 97080

Other trials in Germany

About this study

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

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.

Being tested
Induction chemotherapy with gemcitabine or FOLFIRINOX, Radiotherapy, 28 x 1.8 Gy, Chemotherapy, gemcitabine, Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy
Keywords
pancreatic cancer, chemoradiotherapy, chemotherapy, FOLFIRINOX, gemcitabine
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Induction chemotherapy with gemcitabine or FOLFIRINOXDrug

    Also called all brands of gemcitabine and FOLFIRINOX components are allowed

    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, 28 x 1.8 GyRadiation

    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, gemcitabineDrug

    Also called all brands of gemcitabine are allowed

    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 chemotherapyDrug

    Also called all brands of gemcitabine and FOLFIRINOX components are allowed

    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

Study groups in NCT01827553
Study groupRoleWhat they receive
Induction CT, chemoradiotherapyExperimentalInduction chemotherapy with gemcitabine or FOLFIRINOX; Radiotherapy, 28 x 1.8 Gy; Chemotherapy, gemcitabine;
Receives: Drug: Induction chemotherapy with gemcitabine or FOLFIRINOX; Radiation: Radiotherapy, 28 x 1.8 Gy; Drug: Chemotherapy, gemcitabine
Induction CT, chemotherapyActive comparatorInduction chemotherapy with gemcitabine or FOLFIRINOX; Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy
Receives: Drug: Induction chemotherapy with gemcitabine or FOLFIRINOX; Drug: Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: Participants will be followed for the duration of therapy and for 5 years after the last study treatment

Secondary outcomes (7)

  1. Tumor-free survival

    Measured: 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

    Measured: Participants will be followed for the duration of therapy and for 5 years after the last study treatment

  3. Rate of distant metastasis

    Measured: 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

    Measured: Participants will be followed for the duration of therapy and for 5 years after the last study treatment

  5. Rate of remission

    Measured: Participants will be followed for the duration of therapy and for 5 years after the last study treatment

  6. Rate of curative resections (R0) after chemotherapy and chemoradiotherapy

    Measured: Participants will be followed for the duration of therapy and for 5 years after the last study treatment

  7. Changes in Quality of life

    Measured: Participants will be followed for the duration of therapy and for 5 years after the last study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2013 (estimated)
  2. Study start4 Apr 2013
  3. Primary completion2 Feb 2021
  4. Study completion8 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
830 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01827553
Sponsor's protocol ID
2009-014476-21
Other IDs
2009
Acronym
CONKO-007
Status last verified
Aug 2023
First submitted
4 Apr 2013
Last updated
11 Apr 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 40802908

  • 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.

    PubMed 31640628

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Induction chemotherapy with gemcitabine or FOLFIRINOX, Radiotherapy, 28 x 1.8 Gy and Chemotherapy, gemcitabine in people with Pancreatic Cancer, run by University of Erlangen-Nürnberg Medical School at 23 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01827553, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.

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