A Study to Collect Pre-existing Data on the Administration of Cabozantinib in Participants With Advanced Renal Cell Carcinoma (aRCC) Who Initiated Cabozantinib in 2nd Line in a Real-life Clinical Setting in France.
NCT ID: NCT05444933
Last Updated: 2023-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
252 participants
OBSERVATIONAL
2022-09-16
2023-05-12
Brief Summary
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Cabozantinib effectiveness and safety notably in a real-word setting are now well known, but too many questions that arise during the routine care of patients with aRCC remain unanswered by the current literature.
Obtaining data on cabozantinib effectiveness and treatment pattern in those participants subpopulations will allow physicians to improve patients care.
The aims of this study are to describe the effectiveness - in terms of Duration of Treatment (DOT), Best Overall Response (BOR) and Progression-Free Survival (PFS) - and the safety of second line cabozantinib a real-life setting in France and to address the unanswered questions that arise during the routine care of patients with aRCC treated with cabozantinib in order to improve the care of these participants.
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Detailed Description
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Cabozantinib effectiveness and safety notably in a real-word setting are now well known, but too many questions that arise during the routine care of patients with aRCC remain unanswered by the current literature.
As an example, there is currently no real-world data on cabozantinib in elderly patients (≥ 75 years old); in patients with a systemic therapy after progression under cabozantinib (only one published monocentric retrospective study on 56 participants); or in long responder patients (with a disease controlled after \> 12 months of cabozantinib). Obtaining data on cabozantinib effectiveness and treatment pattern in those patient subpopulations will allow physicians to improve patients care.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Sequencing post-cabozantinib
Participants treated by cabozantinib and who received another systemic therapy post-cabozantinib.
No interventions assigned to this group
Long responders
Participants treated by cabozantinib and who had a disease controlled (CR, PR or SDi during \> 12 months after cabozantinib initiation with or without additional local treatment).
No interventions assigned to this group
Non-responders
Participants treated by cabozantinib and who had a progressive disease less than 3 months after cabozantinib treatment initiation.
No interventions assigned to this group
Cabozantinib & rechallenge
Participants treated by cabozantinib who received systemic therapy and/or had prolonged treatment-free interval (≥ 12 weeks) between two cabozantinib treatment periods. Participants with at least one cabozantinib rechallenge could be included in this subgroup.
No interventions assigned to this group
Cabozantinib & therapeutic schedules
Participants treated by cabozantinib and who needed 1/ a dose increase following disease progression and/or a prior reduction, Or 2/ had any dose reduction/dose interruption of cabozantinib (schedule adaptation).
No interventions assigned to this group
Cabozantinib & local treatment
Participants treated by cabozantinib and who needed concomitant local treatment (LT) by surgery or radiotherapy
No interventions assigned to this group
Cabozantinib & elderly patients
Participants treated by cabozantinib and aged ≥ 75 years
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Pathologically confirmed diagnosis of Renal Cell Carcinoma (RCC) considered as advanced at the time of cabozantinib initiation.
* Cabozantinib initiated from 1st March 2018 to 1st March 2021 for an advanced RCC.
* Cabozantinib initiated in 2nd line according to local Summary of Product Characteristics (SmPC).
Exclusion Criteria
* Participant alive at study initiation who is opposed to data collection.
* Participant who died before study initiation and who was opposed to data collection for research purposes when alive.
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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CHU Amiens
Amiens, , France
CHU Angers
Angers, , France
Institut Sainte Catherine
Avignon, , France
CHU Besançon
Besançon, , France
CHU Bordeaux
Bordeaux, , France
CHRU Brest
Brest, , France
Centre Chirurgie Urinaire et d'Andrologie
Cabestany, , France
CHU Clermont-Ferrand
Clermont-Ferrand, , France
APHP (Créteil)
Créteil, , France
Centre Hospitalier Annecy-Genevois
Épagny, , France
CHU Grenoble
Grenoble, , France
CHU Lille
Lille, , France
CHU Limoges
Limoges, , France
Centre Léon Bérard
Lyon, , France
Hôpital Edouard Herriot
Lyon, , France
Polyclinique de Gentilly
Nancy, , France
CHU Nice
Nice, , France
APHP
Paris, , France
APHP
Paris, , France
APHP (Paris Grenelle)
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
Hospices civils de Lyon
Pierre-Bénite, , France
CH Quimper
Quimper, , France
CHU Reims
Reims, , France
Hôpital Foch
Suresnes, , France
Oncopole CHU Toulouse
Toulouse, , France
CHRU Tours
Tours, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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CLIN-60000-454
Identifier Type: -
Identifier Source: org_study_id
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