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.
- Conditions
- Advanced Renal Cell Carcinoma
- Registration Number
- NCT05444933
- Lead Sponsor
- Ipsen
- Brief Summary
Cabozantinib is an orally bioavailable tyrosine kinase inhibitor (TKI) approved in patients with aRCC previously treated with a Vascular Endothelial Growth Factor (VEGF)-targeted therapy. Cabozantinib has been increasingly used in routine care in second line and more in advanced or metastatic RCC in France.
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.
- Detailed Description
Since 2018, cabozantinib has been increasingly used in routine care in second line and more in advanced or metastatic RCC in France.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 252
- Male or female ≥ 18 age at the time of cabozantinib initiation.
- 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).
- Participant medical file without documented follow-up visits (post-cabozantinib initiation).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of treatment (DOT) of cabozantinib From baseline up to 18 months Defined as the time between first and last intake of cabozantinib treatment, regardless of the treatment discontinuation reason.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS). From baseline up to 18 months Defined as the time from the date of first cabozantinib intake to the date of first documented progression reported by the investigator or death from any cause. Disease progression will be assessed by tumour response evaluation according to investigator assessment.
Reasons for cabozantinib discontinuation From baseline up to 18 months Incidence of all adverse events (AEs). From baseline up to 30 days after cabozantinib last intake Whether they are serious/non-serious, related/unrelated experienced by the participants during cabozantinib treatment period(s).
DOT of subsequent therapy From baseline up to 18 months Best Overall Response (BOR), until disease progression/recurrence From baseline up to 18 months Defined as the proportion of participants achieving the best response among Complete Response (CR), Partial Response (PR), Stable Disease (SDi) or Disease Progression (DP), The method used for the assessment of response to treatment will be left at the discretion of the physician
Incidence of all Special Situations. From baseline up to 30 days after cabozantinib last intake Whether they are serious/non-serious, related/unrelated experienced by the participants
Type of subsequent therapy From baseline up to 18 months Will be described in terms of type, other TKI, Immuno-Oncology therapy (IO), mammalian Target Of Rapamycin (mTOR) inhibitors, other
Starting dose of subsequent therapy From baseline up to 18 months
Trial Locations
- Locations (27)
CHU Besançon
🇫🇷Besançon, France
Hôpital Edouard Herriot
🇫🇷Lyon, France
CHU Amiens
🇫🇷Amiens, France
CHU Angers
🇫🇷Angers, France
Institut Sainte Catherine
🇫🇷Avignon, France
CHRU Brest
🇫🇷Brest, France
CHU Bordeaux
🇫🇷Bordeaux, France
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
Centre Chirurgie Urinaire et d'Andrologie
🇫🇷Cabestany, France
CHU Grenoble
🇫🇷Grenoble, France
Centre Léon Bérard
🇫🇷Lyon, France
APHP (Créteil)
🇫🇷Créteil, France
CHU Lille
🇫🇷Lille, France
CHU Limoges
🇫🇷Limoges, France
CHU Nice
🇫🇷Nice, France
Polyclinique de Gentilly
🇫🇷Nancy, 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
Centre Hospitalier Annecy-Genevois
🇫🇷Épagny, France
Institut Gustave Roussy
🇫🇷Villejuif, France