Clinical trial NCT05444933: 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.
Official title: OCTOPUS: An Observational, Non-interventional, Non-comparative, Retrospective, Multicentre Study in Patients With Advanced Renal Cell Carcinoma (aRCC) Who Initiated Cabozantinib in 2nd Line Under Real-life Setting in France.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Renal Cell Carcinoma
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2022-07-06
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: An estimated total of 300 participants with aRCC and who started cabozantinib in 2nd line between 1st March 2018 and 1st March 2021 is planned to be included. Participants will be enrolled from approximately 25 centers in France

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Duration of treatment (DOT) of cabozantinib
timeFrame: From baseline up to 18 months
Secondary outcomes:
measure: Best Overall Response (BOR), until disease progression/recurrence
timeFrame: From baseline up to 18 months
measure: Progression Free Survival (PFS).
timeFrame: From baseline up to 18 months
measure: Incidence of all adverse events (AEs).
timeFrame: From baseline up to 30 days after cabozantinib last intake
measure: Incidence of all Special Situations.
timeFrame: From baseline up to 30 days after cabozantinib last intake
measure: Type of subsequent therapy
timeFrame: From baseline up to 18 months
measure: DOT of subsequent therapy
timeFrame: From baseline up to 18 months
measure: Starting dose of subsequent therapy
timeFrame: From baseline up to 18 months
measure: Reasons for cabozantinib discontinuation
timeFrame: From baseline up to 18 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: CHU Angers
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Besançon
country: France
facility: CHU Besançon
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Brest
country: France
facility: CHRU Brest
city: Cabestany
country: France
facility: Centre Chirurgie Urinaire et d'Andrologie
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Créteil
country: France
facility: APHP (Créteil)
city: Grenoble
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: CHU Lille
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Nancy
country: France
facility: Polyclinique de Gentilly
city: Nice
country: France
facility: CHU Nice
city: Paris
country: France
facility: APHP
city: Paris
country: France
facility: APHP
city: Paris
country: France
facility: APHP (Paris Grenelle)
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Pierre-Bénite
country: France
facility: Hospices civils de Lyon
city: Quimper
country: France
facility: CH Quimper
city: Reims
country: France
facility: CHU Reims
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: Oncopole CHU Toulouse
city: Tours
country: France
facility: CHRU Tours
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Épagny
country: France
facility: Centre Hospitalier Annecy-Genevois
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: