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.

Advanced Renal Cell Carcinoma Clinical Trial

— OCTOPUS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05444933
• Other study ID #: CLIN-60000-454
• Status: Completed
• Start date: September 16, 2022
• Est. completion date: May 12, 2023

Study information

• Verified date: July 2023
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: May 12, 2023
• Est. primary completion date: May 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Renal Cell Carcinoma
• Carcinoma
• Carcinoma, Renal Cell

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of treatment (DOT) of cabozantinib	Defined as the time between first and last intake of cabozantinib treatment, regardless of the treatment discontinuation reason.	From baseline up to 18 months
Secondary	Best Overall Response (BOR), until disease progression/recurrence	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	From baseline up to 18 months
Secondary	Progression Free Survival (PFS).	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.	From baseline up to 18 months
Secondary	Incidence of all adverse events (AEs).	Whether they are serious/non-serious, related/unrelated experienced by the participants during cabozantinib treatment period(s).	From baseline up to 30 days after cabozantinib last intake
Secondary	Incidence of all Special Situations.	Whether they are serious/non-serious, related/unrelated experienced by the participants	From baseline up to 30 days after cabozantinib last intake
Secondary	Type of subsequent therapy	Will be described in terms of type, other TKI, Immuno-Oncology therapy (IO), mammalian Target Of Rapamycin (mTOR) inhibitors, other	From baseline up to 18 months
Secondary	DOT of subsequent therapy		From baseline up to 18 months
Secondary	Starting dose of subsequent therapy		From baseline up to 18 months
Secondary	Reasons for cabozantinib discontinuation		From baseline up to 18 months