Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004502

Trial Description

start of 1:1-Block title

Title

Non-interventional study to analyse the efectiveness and tolerance of chemotherapy with Docetaxel NC(R) or Doce NC (R) during the treatment of breast cancer and prostate cancer as an application for the daily routine

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The aim of this study is to analyze the tolerance and efficacy of Docetaxel NC(R) and Doce NC(R) in a routine use. Until the implementation of taxanes the prostate carcinoma was indicated as resistant to therapy. A chemotherapy with taxanes will be considered if a tumor is castrationresistant and the health status is apart from that well. The application of Docetaxel can extend the survival period at this stage.

In the situation of a neoadjuvant therapy good results could be achieved with a combination therapy for the treatment of breast cancer. In the metastaziesed situation will be a row of substances like taxanes applied as standard in dependency of distinct therapy requirements for mono-or combination therapies with anthrazyklin and/-or taxane-containing combinations. Also in the polychemotherapy high remission rates with taxane containing combinations were achieved. Potential study participants will be recruited from a patients population, which get within the framework of their therapy a medicamentous treatment with Docetxel NC and Doce NC.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The aim of this non-interventional study is to analyze the tolerance and efficacy of the therapy with Docetaxel (Docetaxel NC and Doce NC) on patients with hormone refractory metastasizing prostate carcinoma or breast cancer. For this purpose the application of the taxane Docetaxel shall be documented in routine use of therapy and diagnostic of the above named diseases. With the accomplishment of this non-interventional study is no intervention meant concerning the choice and performance of therapy, diagnostic and the frequency of examination during or after treatment. The analysis of the tolerance will be carried out by means of the NCI CTC-Checklist version 4.0 for the evaluation of objective side effects. The analysis of the tolerance will be carried out by the means of the objective response.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004502
  •   2012/12/14
  •   [---]*
  •   no
  •   Approved
  •   012/1777, Freiburger Ethik-Kommission International
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
  •   C61 -  Malignant neoplasm of prostate
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients receive chemotherapy with Docetaxel (Docetaxel NC ® and Doce NC ®) according to the medical prescription, which have breast cancer as a disease. The upraised data of the therapy and diagnostic shall be documented in a validated, web-based documentation system ODM QuaSi® of the BNGO.
  •   Patients receive chemotherapy with Docetaxel (Docetaxel NC ® and Doce NC ®) according to the medical prescription, which have prostate cancer as a disease. The upraised data of the therapy and diagnostic shall be documented in the validated, web-based documentation system ODM QuaSi® of the IQUO.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

tolerance evaluated by the NCI CTCAE Criteria

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

efficacy evaluated by the objective response

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/11/01
  •   450
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Histological backed prostate carcinoma or breast cancer, Age over 18 Years, signed patient informed consent, therapy in a practice, which belongs to BNGO or IQUO.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Pregnancy, other malignant diseases in the last 5 years, malignant compliance

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Neocorp GmbH
    • Ms.  Dr.  Sepideh  Fanaei 
    • Am Weidenbach 6
    • 82362  Weilheim
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Urologisch onkologische Schwerpunktpraxis Dr. Geiges
    • Mr.  Dr.med.  Götz  Geiges 
    • Lietzenburger Str. 54
    • 10719  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Onkodatamed GmbH
    • Mr.  Msc  Heribert  Stiegler 
    • August Borsig Ring 37
    • 15566  Schöneiche bei Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Neocorp GmbH
    • Am Weidenbach 6
    • 82362  Weilheim
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   0881 9095960
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/11/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.