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.
OCTOPUS
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.
1 other identifier
observational
252
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Shorter than P25 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2022
CompletedFirst Posted
Study publicly available on registry
July 6, 2022
CompletedStudy Start
First participant enrolled
September 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2023
CompletedJuly 18, 2023
July 1, 2023
8 months
June 30, 2022
July 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Best Overall Response (BOR), until disease progression/recurrence
From baseline up to 18 months
Progression Free Survival (PFS).
From baseline up to 18 months
Incidence of all adverse events (AEs).
From baseline up to 30 days after cabozantinib last intake
Incidence of all Special Situations.
From baseline up to 30 days after cabozantinib last intake
Type of subsequent therapy
From baseline up to 18 months
- +3 more secondary outcomes
Study Arms (7)
Sequencing post-cabozantinib
Participants treated by cabozantinib and who received another systemic therapy post-cabozantinib.
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).
Non-responders
Participants treated by cabozantinib and who had a progressive disease less than 3 months after cabozantinib treatment initiation.
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.
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).
Cabozantinib & local treatment
Participants treated by cabozantinib and who needed concomitant local treatment (LT) by surgery or radiotherapy
Cabozantinib & elderly patients
Participants treated by cabozantinib and aged ≥ 75 years
Eligibility Criteria
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
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (28)
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, 75013, France
APHP
Paris, 75014, France
APHP (Paris Grenelle)
Paris, 75015, 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
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2022
First Posted
July 6, 2022
Study Start
September 16, 2022
Primary Completion
May 12, 2023
Study Completion
May 12, 2023
Last Updated
July 18, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.