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Formal Consensus Method to Evaluate the Conformity of Prescription of a Recently Approved Chemotherapy Treatment in an Observatory Study (CABOBS)

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ClinicalTrials.gov Identifier: NCT02882178
Recruitment Status : Completed
First Posted : August 29, 2016
Last Update Posted : August 30, 2016
Sponsor:
Collaborators:
Sanofi
GECEM
Information provided by (Responsible Party):
Institut Bergonié

Brief Summary:
Cabazitaxel is a second line chemotherapy drug recently approved for the treatment of metastatic castration-resistant prostate cancer. To investigate whether the precautions for the use of cabazitaxel (contraindications, hepatic function, premedication for hypersensitivity, prophylactic treatments, dose and dose adjustment, as well as conditions of administration) are respected in routine practice, an observational cohort study will be implemented in 32 oncology centres of South-West region of France (CABOBS study). The primary objective of this cohort is to evaluate the conformity of cabazitaxel prescriptions with the Summary of Product haracteristics (SPC) in clinical practice (indications and monitoring methods) and according to the conditions of use. Panel of experts were convened to assess the conformity of prescription of cabazitaxel with a Delphi consensus method. The Delphi method is most suited to areas where a limited number of evidences are available to enable a recommendation or guidelines to be drawn. Moreover, all the evaluated items came from an official document provided by the EMA, the SPC of cabazitaxel. Thus, it is expected from the experts to select the most relevant items. In the frame of the CABOBS study, this method will allow to select items of the SPC list according to their importance, and to define the primary objective of conformity to cabazitaxel conditions of use.

Condition or disease
Prostate Cancer

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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Case Control
Study Start Date : November 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. conformity to cabazitaxel conditions of use [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
metastatic castration-resistant prostate cancer
Criteria

Inclusion Criteria:

  • metastatic castration-resistant prostate cancer
  • older than 18

Exclusion Criteria:

-


Publications of Results:
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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT02882178    
Other Study ID Numbers: IB2012-CABOBS
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut Bergonié:
Prostate cancer
cabazitaxel
consensus
conformity
prescription
conditions of use
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases