Clinical trial · Observational
Study on the Utilization of Cabozantinib in Adult Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) in 2nd Line Treatment Following Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Therapy Under Real-real Life Clinical Setting in France.
CAROLINE: An Observational, Prospective, Multicenter Study, on the Utilization of Cabozantinib in Adult Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) in 2nd Line Treatment Following Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Therapy Under Real-real Life Clinical Setting in France.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unfavorable opinion of IRB/IEC
Summary
Brief summary (as posted)
The purpose of the protocol is to assess the Overall Survival (OS) at 1 year in patients after cabozantinib initiation.
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 |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival (OS) rate at 1 year after cabozantinib initiation
- timeFrame
- up to 12 months
- description
- OS is the time between treatment initiation and the date of death from any cause. For participants who are alive, their survival time will be censored at the last date that they were known to be alive if before 1 year.
Secondary outcomes (10)
- measure
- Objective Response Rate (ORR) at 1 year
- timeFrame
- Day 15, 1 month, 3, 6 and 12 months
- description
- ORR is defined as the proportion of participants who achieve partial or complete response from the start of the study treatment. The ORR will be assessed by tumour response evaluation according to investigator assessment. Tumour response will be evaluated per routine clinical practice by the physician.
- measure
- Best Overall Response (BOR) at 1 year
- timeFrame
- Day 15, 1 month, 3, 6 and 12 months
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 (Clear Cell or non-Clear Cell) cancer considered as advanced or metastatic at the time of cabozantinib initiation * Intention to be treated with cabozantinib tablets according to the current local Summary of Product Characteristics (SmPC) (France) * Initiating cabozantinib as a second line of treatment (Baseline visit must be performed before cabozantinib first intake) Exclusion Criteria: * He/she is already included in an interventional trial with an investigational product at the same time.
References
Publications (0)
Data not yet available