Trial document




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  DRKS00000712

Trial Description

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Title

Non-interventional study concerning efficacy and safety of the intraperitoneal therapy with Removab(R) under routine practice conditions: Ambulant Catumaxomab Therapy: ACT

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of this non-interventional study is the assessment of the therapeutical efficacy of Removab(R) by means of the main parameters "Punction-free interval after the last Removab(R) infusion" and "Quality of life concerning the Ascites symptoms".
Malign Ascites is a frequent problem with tumor diseases and occurs by spreading of the tumor cells in the peritoneal area.
Removab(R) (Catumaxomab) is a tri-functional monoclonal antibody which targets a tumor-associated antigen.
Participants of the study are patients with the primary disease Mamma Carcinom, Cervix Carcinom or Ovarial Carcinom, who are treated by a gynaecological oncologist who is a member of the Professional Association of Practice-based Gynaecological Oncologists in Germany (BNGO).

The intra-peritoneal treatment with Removab(R) is performed in the physician's sole discretion usually 4 times with an interval of 3-4 days. Furthermore 2 follow-ups are performed 4-6 weeks and 15-17 weeks after the last infusion.

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Brief Summary in Scientific Language

It is the aim of this non-interventional study to collect information about the efficacy and agreeableness of the intraperitoneal therapy of Removab(R) under routine practice conditions.
According to the criteria of a NIS the treatment solely follows the product information and the therapy-plan of the physician.
Key parameters for the judgement of the therapeutical efficacy are: punction-free interval after the last infusion of Removab(R), quality of life of the patients regarding the Ascites symptoms.
Furthermore data concerning the agreeableness of the product will be verified, because so far there are only results of clinical studies available.
Besides that the patient population will be characterized concerning primary tumor and pre-therapies
Overall survival data will be collected in a post-study phase.

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Organizational Data

  •   DRKS00000712
  •   2011/03/04
  •   [---]*
  •   no
  •   Approved
  •   011/1056, Freiburger Ethik-Kommission International
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Secondary IDs

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Health Condition or Problem studied

  •   Malign Ascites
  •   R18 -  Ascites
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Interventions/Observational Groups

  •   Observation group: Intraperitoneal infusion of Removab(R).
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Puncture-free interval after last Removab infusion

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Secondary Outcome

Quality of life regarding Ascites symptoms.
Time of measurement: Infusions 1 - 4 and follow-ups 1 and 2.
Method of measurement: FACIT Ascites questionnaire.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/06/03
  •   50
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   30   Years
  •   80   Years
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Additional Inclusion Criteria

Malign Ascites.
Patients can be included on first diagnosis and treatment recommendation with Removab(R) by the physician

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Exclusion Criteria

By physician's judgement

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Addresses

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    • Fresenius Biotech GmbH
    • Dr.med.  Mirko  Essing 
    • Frankfurter Ring 193a
    • 80807  München
    • Germany
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    • Fresenius Biotech GmbH
    • Ms.  Dr.med.  Elisabeth   Urban 
    • Frankfurter Ring 193a
    • 80807  München
    • Germany
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    • OnkoDataMed GmbH
    • Mr.  M.Sc.  Heribert  Stiegler 
    • August-Borsig-Ring 37
    • 15566  Schöneiche b. Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Fresenius Biotech GmbH
    • Ms.  Dr.med.  Elisabeth  Urban 
    • Frankfurter Ring 193a
    • 80807  München
    • 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.