Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005213

Trial Description

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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

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Trial Acronym

CONKO-007

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005213
  •   2013/08/13
  •   2013/04/04
  •   yes
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Secondary IDs

  •   2009-014476-21 
  •   NCT01827553  (ClinicalTrials.gov)
  •   2009-014476-21  (University of Erlangen-Nürnberg Medical School)
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Health Condition or Problem studied

  •   Pancreatic Cancer
  •   C25 -  Malignant neoplasm of pancreas
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Interventions/Observational Groups

  •   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
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Factorial
  •   III
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Primary Outcome

- Overall survival; time frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment

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Secondary Outcome

- Tumor-free survival; time frame: 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
- Rate of distant metastasis; time frame: 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
- Quality of life; time frame: 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
- 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2013/03/31
  •   830
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • University of Erlangen-Nürnberg Medical School
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    • Strahlenklinik, Universitätsklinikum Erlangen
    • Rainer Fietkau, MD 
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    • Rainer Fietkau, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   379
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.