Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01827553
Recruitment Status : Recruiting
First Posted : April 9, 2013
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Tracking Information
First Submitted Date  ICMJE April 4, 2013
First Posted Date  ICMJE April 9, 2013
Last Update Posted Date June 20, 2019
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2013)
Overall survival [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01827553 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • 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 Name: 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 Name: all brands of gemcitabine 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 Name: all brands of gemcitabine and FOLFIRINOX components are allowed
Study Arms  ICMJE
  • Experimental: Induction CT, chemoradiotherapy
    Induction chemotherapy with gemcitabine or FOLFIRINOX; Radiotherapy, 28 x 1.8 Gy; Chemotherapy, gemcitabine;
    Interventions:
    • Drug: Induction chemotherapy with gemcitabine or FOLFIRINOX
    • Radiation: Radiotherapy, 28 x 1.8 Gy
    • Drug: Chemotherapy, gemcitabine
  • Active Comparator: Induction CT, chemotherapy
    Induction chemotherapy with gemcitabine or FOLFIRINOX; Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy
    Interventions:
    • Drug: Induction chemotherapy with gemcitabine or FOLFIRINOX
    • Drug: Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2013)
830
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rainer Fietkau, MD ++49(0)9131 85 ext 33968 st-studiensekretariat@uk-erlangen.de
Contact: Sabine Semrau, MD ++49(0)9131 85 ext 33968 st-studiensekretariat@uk-erlangen.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01827553
Other Study ID Numbers  ICMJE 2009-014476-21
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Erlangen-Nürnberg Medical School
Study Sponsor  ICMJE University of Erlangen-Nürnberg Medical School
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rainer Fietkau, MD Strahlenklinik, Universitätsklinikum Erlangen
PRS Account University of Erlangen-Nürnberg Medical School
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP