Clinical trial · Observational

Consensus Method to Evaluate the Conformity of Prescription of a Chemotherapy

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

NCT02882178CI-TRIAL-00049332CABOBScompletedResults postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Items to Define Conformity to Cabazitaxel Conditions of Use
timeFrame
Baseline
description
Items selected by the consensus process to assess the conformity of prescription of cabazitaxel based on the the 26 items included in the Summary of Product Characteristics (SPC). Two independent panels of experts in the field of uro-oncology, one French panel and a European panel from the Genito-Urinary group of the European Organization for Research and Treatment of Cancer (EORTC-GU), were solicited in order to define the importance of each criterion of the SPC and to allow a qualitative assessment of conformity using a formal consensus method. The purpose of consensus methods is to assess the extent of agreement and to resolve disagreement among a group of selected individuals by identifying and selecting, through iterative ratings with feedback, specific points on which there is disagreement or uncertainty. We relied on the Delphi method as it is most suited to areas where a limited number of evidences are available to enable a recommendation or guidelines to be drawn.

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 18 Years

Show eligibility criteria text

Eligibility criteria for the experts involved in the consensus process:

1. experts in uro-oncology solicited within the French GETUG's group (Groupe d'Etude des Tumeurs Uro-Génitales)
2. experts in uro-oncology solicited within the EORTC GU group for the second panel of experts.

References

Publications (1)

RESULTHouede N, Leutenegger E, Lomma M, Bellera C. Formal consensus method to evaluate the conformity of prescription of a recently approved chemotherapy treatment in an observatory study. PLoS One. 2015 Apr 2;10(4):e0123035. doi: 10.1371/journal.pone.0123035. eCollection 2015. PMID 25837603