Clinical trial · Observational
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: 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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (7)
- label
- Sequencing post-cabozantinib
- description
- Participants treated by cabozantinib and who received another systemic therapy post-cabozantinib.
- label
- Long responders
- description
- 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).
- label
- Non-responders
- description
- Participants treated by cabozantinib and who had a progressive disease less than 3 months after cabozantinib treatment initiation.
- label
- Cabozantinib & rechallenge
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available