Trial document





This trial has been registered retrospectively.
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  DRKS00004794

Trial Description

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Title

axiplatin - noninterventional observational study

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Trial Acronym

NIS-axiplatin

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this non-interventional study, the treatment for colon cancer stage III (Dukes' C) and metastatic colorectal cancer is documented in patients who receive axiplatin ® under SPC ( summary of product characteristics). Contraindications and special warnings and precautions for the SPC axiplatin ® should be followed.

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Brief Summary in Scientific Language

The aim of this non-interventional study is to document in accordance with § 67 paragraph 6 of the AMG the use, effectiveness and safety of axiplatin® in the treatment of colon cancer stage III (Dukes C) and advanced colorectal cancer. The inclusion in this study does not influence the physicians in their choice of therapy and diagnostic methods during and after treatment. In terms of drug safety, an evaluation of the general tolerability shall contribute to the ongoing benefit / risk evaluation under routine practice conditions.

This involves the detailed characterization and monitoring of all common side effects of all cytostatics being applied for said indications under clinical routine. These side effects concern mainly hematological toxicities (for example neutropenia, thrombocytopenia) and non-hematological toxicities (diarrhea, palmar-plantar erythrodysesthesia syndrome, etc.).
In order to get the current picture of the therapy situations it will be inquired whether particular settings like dose reduction or patient profiles have influence on the frequency, severity or progression of hematological and non-hematological toxicities. Because hematologic toxicity under therapy with axiplatin ® may result in anemia, leukopenia, thrombocytopenia or neutropenia, an ongoing monitoring of corresponding laboratory values is part of the analysis.

The data obtained in pivotal studies are based on patient population estimations which are performed by statistical state of art procedures. However, due to inclusion and exclusion criteria defined by study protocols the resulting study populations may represent only a non-representative subset in terms of a real-life setting. Therefore no protocol defined inclusion or exclusion criteria will restrict the scope of additional information of this observational study. The participating practices will recommend the treatment option with axitaxel® to all potential study patients based on the SPC and the physicians’ expertise. Thus the patient population of this observational study is the result of a real-life diagnostic and therapeutic scenario. This non-interventional study (NIS) will make additional efficacy data available under said daily routine conditions, which means it will deliver additional efficacy data after marketing authorization. In particular also additional safety information will be obtained by using GCP conform documentation and reporting procedures. As a consequence the spontaneous pharmacovigilance reporting system as defined by the German Drug Law § 62 et seq. will be supported and the awareness of participating sites for adherence to said legal and ethical requirements will be sharpened.

1. Is the treatment outcome depending on the number of cycles following toxicity induced dose reduction?
2. What are the reasons leading to dose alteration and premature discontinuation?
3. Can the efficiency shown by pivotal studies be confirmed in clinical practice?
4. What dose levels and regimes (combined compounds) are applied?
5. Is the therapy outcome different between the applied therapy regimes?
6. Which conventional prognostic factors are in practice of primary importance for the efficacy of treatment with axiplatin® in advanced colorectal cancer and colon carcinoma stage III (Dukes C)?
7. How is the rate of side effects in clinical practice in combination with said underlying regimens?
8. Can unknown side effects in the routine use of axiplatin® be observed? Treatment of gastric cancer will not be documented according to the Amendment of 16-Oct-2013.

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Organizational Data

  •   DRKS00004794
  •   2013/03/06
  •   [---]*
  •   no
  •   Approved
  •   Eth-06/12, Ethik-Kommission des Landes Berlin
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   Dokumenation of therapy in patients where treatment with axiplatin® against colon cancer an stage III (Dukes' C), metastatic colorectal cancer is indicated according to SPC.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   No
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Primary Outcome

Complete remission at end of observation period assessed by clinical examination or imaging.

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Secondary Outcome

Toxicities of grade IV during treatment period diagnosed through clinical examination or laboratory.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2012/05/03
  •   500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Informed Consent; malignant neoplasm of colon, rectosigmoid junction and rectum.

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Exclusion Criteria

/

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Axios Pharma GmbH
    • Mr.  Wolfgang  Seppich 
    • Kammerichstrasse 39
    • 33647  Bielefeld
    • Germany
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    •   +49 521 98 83 50
    •   +49 521 97 17 478
    •   [---]*
    •   [---]*
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    • Datafaber GbR
    • Mr.  Dr  Burkard  Heckelbacher 
    • Kantstrasse 15
    • 85356  Freising
    • Germany
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    • Axios Pharma GmbH
    • Mr.  Wolfgang  Seppich 
    • Kammerichstrasse 39
    • 33647  Bielefeld
    • Germany
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Sources of Monetary or Material Support

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    • Axios Pharma Gmbh
    • Mr.  Wolfgang  Seppich 
    • Kammerichstr. 39
    • 33647  Bielefeld
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/01/22
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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.