Trial document




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  DRKS00012595

Trial Description

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Title

5-Fluorouracil (5-FU), folinic acid and irinotecan (FOLFIRI) versus 5-FU and folinic acid as second-line chemotherapy in patients with biliary tract cancer (IRIBIL): a randomized open-label phase 2 study

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Trial Acronym

AIO-YMO/HEP-0316-IRIBIL

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URL of the Trial

http://liegt noch nicht vor

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Brief Summary in Lay Language

This study will evaluate the combination therapy of FOLFIRI in comparison to 5-FU/folinic acid monotherapy in patients with advanced cholangiocarcinoma or gallbladder cancer.

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Brief Summary in Scientific Language

This randomized study will evaluate the combination therapy of FOLFIRI in comparison to 5-FU/folinic acid monotherapy. It will be evaluated if the combination therapy shows an improvement in progression-free survival. Furthermore, overall survival, the time until progression and the quality of live will be assessed.

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Organizational Data

  •   DRKS00012595
  •   2017/06/16
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  •   yes
  •   Approved
  •   157/16F, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

  •   2015-004028-69 
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Health Condition or Problem studied

  •   C22 -  Malignant neoplasm of liver and intrahepatic bile ducts
  •   C23 -  Malignant neoplasm of gallbladder
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Interventions/Observational Groups

  •   5-Fluoruracil, Folinic acid and Irinotecan (FOLFIRI), infusion, every 2 weeks
  •   5-Fluoruracil, Folinic acid, infusion, every 2 weeks
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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
  •   Parallel
  •   II
  •   No
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Primary Outcome

Determination of the progression free survival (PFS)
Treatment will be continued until one of the following occurs:
• progressive disease (PD),
• not tolerable toxicity
• patient’s wish,
• other reasons according to which continuation of treatment is not in the patient’s best interest

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Secondary Outcome

Determination of
• overall survival (OS)
• time to progression (TTP) by RECIST 1.1, every 8 weeks
• overall response rate (either complete response, CR, or partial response, as measured by RECIST 1.1
• safety profile
• quality of life (EORTC QLQ-C30 questionnaire), every 2 weeks

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2017/08/10
  •   56
  •   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

• Written informed consent granted prior to initiation of any study specific screening procedures
• Patients with histologically confirmed CCA or GB-CA not suitable for resection or metastatic
• Progressive disease undergoing a systemic chemotherapy with a platin-derivate (Oxaliplatin, Cisplatin or Carboplatin) and Gemcitabine or progressive disease within 3 months after cessation of chemotherapy
• Age < 18 years
• Performance status ECOG 0-2
• Normal organ and bone marrow function defined as:
o Hematopoetic: absolute neutrophil count >1,500/mm3, platelet count >75,000/mm3, hemoglobin >9 g/dL
o INR ≤ 1.5
o Hepatic: AST or ALT < 5 x ULN, bilirubin ≤ 2 mg/dl
o Renal: serum creatinine < 1.5 x ULN
• Child Pugh stage A in patients with cirrhosis (Appendix 21.2)
• Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the randomization
• Male or female patients of child-bearing potential must agree to use oral contraception, intrauterine device, bilateral tubal occlusion, vasectomised partner or avoidance of intercourse during the study and for 180 days after last investigational drug dose received

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Exclusion Criteria

• CCA or GB-CA amendable for surgical resection
• Prior radiation therapy, chemoradiation, transarterial chemoembolisation (TACE), Radiofrequency ablation (RFA) or selective intraarterial Radiotherapy (SIRT) within the last 3 months, radiation of symptomatic bone metastasis is allowed
• Concomitant photodynamic therapy or intraductal radiofrequency ablation within the last 8 weeks
• Child Pugh stage B or C (> 6 points) in patients with cirrhosis
• Massive, uncontrolled ascites
• Systemic anticancer chemotherapy other than Gemcitabin and a platin derivate (Cisplatin, Carboplatin or Oxaliplatin)
• Cardiac disease: congestive heart failure > class II NYHA
• Known uncontrolled brain metastasis
• History of bone marrow or organ allograft
• Active clinically serious infections > CTCAE grade 2 beside of chronic hepatitis C virus infection
• Major surgery within 4 weeks of first dose of study drug, port implantation is allowed
• Known or suspected allergies to 5-FU, folinic acid, irinotecan or other constituent materials or a known dihydropyrimidin-dehydrogenase deficiency
• Previous cancer that is distinct in primary site or histology from CCA or GB-CA except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated 3 years prior to study entry
• Substance abuse, medical or psychological condition that may interfere with the patient´s participation in the study
• Participation in another clinical trial with any investigational study drug (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to enrollment
• Pregnancy or breast feeding women
• Concomitant treatment with Brivudin, Sorivudin or their analogues or use of St. John's wort
• severe diarrhea
• inflammatory bowel disease and/or ileus
• Incapability to give valid informed consent (including patients who are dependent on the sponsor or the investigator)

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Addresses

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    • Dekanat des Fachbereichs MedizinUniversitätsklinikum der Goethe-Universität Frankfurt
    • Mr.  Prof.  Josef  Pfeilschifter 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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    • Universitätsklinikum der Goethe-Universität FrankfurtMedizinische Klinik 1
    • Mr.  Prof. Dr. med.  Oliver  Waidmann 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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    • Universitätsklinikum der Goethe-Universität FrankfurtMedizinische Klinik 1
    • Mr.  Prof. Dr. med.  Oliver  Waidmann 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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Sources of Monetary or Material Support

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    • medac Gesellschaft für klinische Spezialpräparate mbH
    • Theaterstraße 6
    • 22880  Wedel
    • Germany
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    • Universitäres Zentrum für Tumorerkrankungen (UCT) über das Hessisches Onkologie Konzept)
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.