Trial document





This trial has been registered retrospectively.
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  DRKS00005456

Trial Description

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Title

Non-interventional study about the tolerability and efficacy of chemotherapy with Oxaliplatin (Euroxaliplatin(R)) in everday use for treatment of the colorectal carcinoma

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Trial Acronym

ABC-Study/002

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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 to determinate the tolerability and efficacy of chemotherapy with Euroxaliplatin in patients with colorectal carcinoma. In this context age, BMI and comorbidity of the patients are taken into account. For that purpose the application of Euroxaliplatin as part of routine therapy and diagnostics of this disease is to be documented in this investigation. In the analysis of the data it should be determined, if age has an impact on the choice of therapy regimen or if age has an impact on the therapy result. According to that it should be determined, if the initial BMI and the comorbidity as well as the physical activity have an impact on the therapy result overall respectively on the different treatment groups.
As part of the process of this non-interventional study there is no intervention regarding to the choice and conduction of therapy, the diagnostics and intervals of examination during and after the treatment. The assessment of tolerability is carried out by using the CTC-checklist Version 4.0 to evaluate objective adverse reactions. The assessment of effectiveness is carried out by evaluating the objective response rate.

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Brief Summary in Scientific Language

In 2008 the colorectal carcinoma was the second most common cancer in both male and female. As well as for women and for men it ist furthermore the second most common cause of death following a cancer disease. The risk factors for colonal and rectal carcinoma are largely identical.
For adjuvant chemotherapy of the colonal carcinoma in stadium III it is recommended to use a Oxaliplatin-based therapy following the S3-Guideline und the Guideline Coloncarcinoma of DGHO.
In the context of this non-interventional study the tolerability and efficacy of chemotherapy with Euroxaliplatin in patients with colorectal carcinoma should be determined. The primary target parameters are:
- impact of age (≤65 years versus >65 years)
- impact of BMI (<19 kg/m2 versus 19-30 kg/m2 versus >30 kg/m2)
- impact of comorbidity
on therapy and tolerability.
It is planned to recruit about 15-20 study centres from oncological private practices in Germany. Thereby the representativity of the data for Germany is ensured.
500 patients should be included in this case series, whereby a recruiting period of 3 years is planned. The individual period of documentation for each patient amounts approx. 9 months.
For the purpose of this non-interventional study those patients who are suffering from colorectal carcinoma are incorporated in this study, which require a medical treatment. The physician in charge made the decision that the incorporated patient shall receive a therapy with Euroxaliplatin following the guidelines. The selection of patients is at the physician's discretion. The expert information of Euroxaliplatin is considered as guideline.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005456
  •   2014/01/07
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  •   no
  •   Approved
  •   FF 107/2013, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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Health Condition or Problem studied

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

  •   Use of Euroxaliplatin in combination with 5-Fluorouracil und Folinsäure
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Characteristics

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

Impact of age, BMI and comorbidity on therapy and tolerability (CTC-checklist version 4.0), effectiveness (objective response rate)

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Secondary Outcome

Progression Free Survival (PFS), impact of physical activity (questions as listed in the eCRF)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • other 
  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2013/11/15
  •   500
  •   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

• Histologically confirmed colorectal carcinoma
• Age: ≥ 18 years
• Signed informed consent
• Capacity of the patient to consent (knowledge of manner, significance and consequences of medical operations)
• Adequate pregnancy prevention measures during the cytostatic therapy
• Therapy in an oncological doctors practice

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Exclusion Criteria

• Pregnancy (in female patients)
• Period of lactation (in female patients)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Lapharm GmbH
    • Mr.  Rüdiger  Heffinger 
    • Wittelsbacherstr. 9
    • 83022  Rosenheim
    • Germany
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    • Facharztpraxis für Innere Medizin (Gastroenterologie, Hepatologie, Onkologie)
    • Mr.  Prof. Dr. med.  Hanns  Löhr 
    • Luisenstraße 26
    • 65185  Wiesbaden
    • Germany
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    • OnkoDataMed GmbH
    • Ms.  Anne-Katrin  Ullner 
    • Friedenstraße 58
    • 15366  Neuenhagen bei Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Lapharm GmbH
    • Mr.  Rüdiger  Heffinger 
    • Wittelsbacherstr. 9
    • 83022  Rosenheim
    • 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.