Trial document




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  DRKS00017416

Trial Description

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Title

Transarterial chemoembolization (TACE) with Irinotecan and Mitomycin C versus TACE with Doxorubicin in patients with Hepatocellular carcinoma not amenable to curative treatment - IRITACE- a randomized multicenter phase 2 trial. A trial of the German Alliance for Liver Cancer (GALC).

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Trial Acronym

IRITACE

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URL of the Trial

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Brief Summary in Lay Language

Iritace is a hypothesis-driven clinical trial in HCC (Hepatocellular carcinoma) patients comparing TACE with Mitomycin C and Irinotecan (both agents already approved for clinical application) to Doxorubicin-based TACE which is regarded a current standard.

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Brief Summary in Scientific Language

Iritace is a hypothesis-driven clinical trial in HCC patients comparing TACE with Mitomycin C and Irinotecan (both agents already approved for clinical application) to Doxorubicin-based TACE which is regarded a current standard.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

Not applicable

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Organizational Data

  •   DRKS00017416
  •   2020/03/10
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  •   yes
  •   Approved
  •   19-417-AMG, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

  •   2019-000922-23 
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Health Condition or Problem studied

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

  •   DEB TACE with 10 mg Mitomycin C and 200 mg Irinotecan coupled to 4 ml 70-150 μm beads TACE with Irinotecan and Mitomycin C. Mitomycin C has to be administered before Irinotecan.
  •   DEB TACE with Doxorubicin 150 mg coupled to 4 ml 70-150 μm beads.
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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

Progression free survival (PFS) time

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Secondary Outcome

overall survival (OS);
response/disease control rate (DCR) (either complete response, CR, or partial response, as measured by mRECIST for HCC);
time to progression;
time to macrovascular invasion/extrahepatic spread (MVI/EHS);
time to unTACEable progression;
safety profile;
quality of life (as measured by FACT-Hep and FACT-G7 questionnaires)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/06/08
  •   104
  •   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

1. Written informed consent granted prior to initiation of any study specific screening procedures
2. Patients with histologically confirmed HCC primarily not suitable for resection, ablation or liver transplantation. A combined therapy with TACE and subsequent ablation is possible.
3. Availability of Biopsy for translational research, if patients give their consent
4. Absence of extrahepatic spread
5. Age ≥ 18 years
6. Patients with measurable disease according to mRECIST
7. Performance status ECOG 0 and 1 (Appendix 20)
8. Normal organ and bone marrow function defined as:
– Hematopoetic: absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 60 x 109/l, hemoglobin ≥ 9 g/dL
– INR ≤ 1.5 x ULN
– Hepatic: AST and ALT < 5 x ULN, bilirubin ≤ 2 mg/dl
– Renal: serum creatinine ≤ 1.5 x ULN
9. Child-Pugh stage A
10. Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolment
11. Male or female patients of child-bearing potential must agree to use oral contraception, intrauterine device, bilateral tubal occlusion, vasectomized partner or avoidance of intercourse during the study and for 180 days after last investigational drug dose received

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Exclusion Criteria

1. Extrahepatic tumor manifestation
2. Tumor infiltration of more than 50% of the whole liver mass
3. Infiltration or thrombosis of the main portal vein or the main left or right intrahepatic branches
4. Child Pugh status B or C > 6 points according to Child Pugh classification (Appendix 20)
5. Prior TACE or selective intraarterial Radiotherapy (SIRT)
6. Prior systemic anticancer therapy for HCC
7. Life expectancy of less than 12 weeks
8. Esophageal varices grade III (any) or esophageal varices grade II with increased risk for bleeding (red wale signs, cherry spots, red coloration, hematocystic spots) without prophylactic band ligation
9. Known or suspected manifest hyperthyroidism
10. Congestive heart failure > class II NYHA (Appendix 20)
11. Cardiac ventricular arrhythmias requiring antiarrhythmic therapy, acute myocardial infarction, myocardial infarction, acute inflammatory heart disease > CTCAE grade 2 within the past 6 months (Appendix 20)
12. Previous treatment with doxorubicin up to the maximum lifetime dose of 550mg/m2
13. History of organ allograft or bone marrow transplantation
14. Active uncontrolled clinically serious infections > CTCAE grade 2 except chronic hepatitis C infection (Appendix 20)
15. Severe restrictive or obstructive lung disease
16. Clinically apparent chronic inflammatory bowel disease and/or ileus
17. Hemorrhage/bleeding event or variceal bleeding > CTCAE grade 2 within 4 weeks of first dose of study drug (Appendix 20)
18. Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug
19. Known or suspected allergies to Iodine-containing or Gadolinum-containing contrast medium, Irinotecan, Mitomycin C, Doxorubicin or other inactive ingredients of the drugs
20. Previous cancer that is distinct in primary site or histology from HCC except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated 3 years prior to study entry
21. Concomitant treatment with St. John's wort
22. Substance abuse, medical, psychological or social condition that may interfere with the patient´s participation in the study
23. Participation in another clinical trial with any investigational study drug (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to enrollment
24. Incapability to give valid informed consent (including patients who are dependent on the sponsor or the investigator)
25. Pregnancy or breast-feeding women

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Addresses

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    • Dekanat des Fachbereichs Medizin Klinikum der Johann Wolfgang Goethe-Universität, Haus 1
    • Mr.  Prof. Dr. med.  Stefan  Zeuzem 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • 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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    • Else-Kröner-Fresenius-Stiftung
    • 61348  Bad Homburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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