Trial document





This trial has been registered retrospectively.
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  DRKS00011482

Trial Description

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Title


CORNELIUS (COloRectal CaNcEr in ELderly MultImorbide PopUlationS): a non-interventional observational study

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Trial Acronym

CORNELIUS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this non-interventional study, therapy of patients with colon carcinoma stage III (Dukes C) or with inoperable advanced or metastasizing colon carcinoma is going to be documented, where treatment with oxaliplatin or axinotecan is indicated according to SPC. Contraindications and special warnings and precautions for the treatment with oxaliplatin or axinotecan SPC should be followed. All eligible patients should be included without any pre-selection in order to get a realistic picture of the practice routine.

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Brief Summary in Scientific Language

This non-interventional study (NIS) CORNELIUS has been designed for the documentation of use of axinotecan (active agent: irinotecan) or oxaliplatin in daily oncological practice routine.
The aim of this non-interventional trial is, in accordance with § 67 paragraph 6 of the AMG, to collect data which can be analyzed in terms of use, efficacy and safety of axinotecan or oxaliplatin in various therapy regimens in patients with colon carcinoma stage III (Dukes C) or patients with inoperable advanced or metastasizing colon carcinoma.
Inclusion of patients in this NIS must not have influence on the doctors’ decisions regarding diagnostics and therapy plan during and after treatment.

This NIS is conducted in order to investigate the safety profiles of oxaliplatin and axinotecan. The analysis of tolerability of both medications shall contribute to the risk-benefit assessment in daily practice. Adverse drug reactions of oxaliplatin or axinotecan shall be documented within the scope of typical conditions of use, especially hematological toxicity (e.g. neutropenia, thrombocytopenia) and non-hematological toxicity (e.g. diarrhea, palmar-plantar erythrodysesthesia or neuropathy).
In particular, the participants shall collect data regarding the impact of therapy regimen (also dose adjustments) and characteristics of the patients such as age-appropriate general condition and comorbidities on frequency, severity and course of adverse drug reactions. That includes laboratory investigations of anemia, leukopenia, thrombocytopenia and neutropenia.

In contrast to clinical studies, non-interventional observational studies investigate patients under daily routine. The present study is a prospective study without study interventions in order to get a realistic picture of the use of axinotecan or oxaliplatin in practice routine. Thus, the study is ideally suited for investigation of open questions that could not be answered in clinical studies due to smaller and selected patient populations.

The study focuses on the following issues:

1. How do modifications of dosage and treatment cycles influence the therapy results under daily practice routine?

2. How often lead adverse drug reactions to modification of dosage and/or discontinuation of treatment?

3. Are the therapy results of the investigated medications comparable with the data from the approval study?

4. Are the patient-specific factors such as age-appropriate general condition and comorbidities under daily routine comparable with the patient characteristics in the approval study?

5. Are there adverse drug reactions under therapy with axinotecan or oxaliplatin which were not observed so far?

The NIS shall be carried out at 150 outpatient oncologists, internal oncologists and gastroenterologists. It is planned to include 800 patients in total.

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Organizational Data

  •   DRKS00011482
  •   2016/12/15
  •   [---]*
  •   no
  •   Approved
  •   FF 32/2016, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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Health Condition or Problem studied

  •   C18 -  Malignant neoplasm of colon
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Interventions/Observational Groups

  •   Efficacy and safety profile of oxaliplatin or axinotecan will be documented under routine practice conditions in patients where treatment with oxaliplatin or axinotecan is indicated. No further pre-selection is allowed. Descriptive analysis will be performed. Side effects which were not observed so far will be reported
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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

Efficacy and tolerability of oxaliplatin or axinotecan in routine practice

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Secondary Outcome

Side effects which were not reported so far

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2016/10/28
  •   800
  •   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

- Signed and dated consent is available
- The treatment decision was made independently of a possible inclusion in the study
- Patient is not at the same time a clinical trial participant
- Patient is at least 18 years old.

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Exclusion Criteria

According to contraindications and special warnings in the SPCs axinotecan 20 mg/ml and oxaliplatin.

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Addresses

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    • axios Pharma GmbH
    • Kammerichstr. 39
    • 33647  Bielefeld
    • Germany
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    • INPADS GmbH
    • Dr. Hugo-Bischoff-Str. 1a
    • 67098  Bad Dürkheim
    • Germany
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    • Internistische Gemeinschaftspraxis / Onkologische Schwerpunktpraxis / Gastroenterologie
    • Mr.  Prof. Dr.  Gernot  Hartung 
    • Wilhelm-Seipp-Str.3
    • 64521  Groß-Gerau
    • Germany
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    • axios Pharma GmbH
    • Mr.  Dr.  Andreas  Schuster 
    • Kammerichstr. 39
    • 33647  Bielefeld
    • Germany
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Sources of Monetary or Material Support

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    • axios Pharma GmbH
    • Kammerichstr. 39
    • 33647  Bielefeld
    • 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.