Clinical trial NCT04609800: 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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Renal Cell Carcinoma
Keywords: Renal Cell Carcinoma (clear cell or non-clear cell)
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2020-10-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Data of 195 participants suffering from advanced or metastatic RCC and treated with cabozantinib will be collected. During the study, two questionnaires (FKSI 19 and BPI-SF) will be filled in by patients.

Brief summary: The purpose of the protocol is to assess the Overall Survival (OS) at 1 year in patients after cabozantinib initiation.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS) rate at 1 year after cabozantinib initiation
timeFrame: up to 12 months
Secondary outcomes:
measure: Objective Response Rate (ORR) at 1 year
timeFrame: Day 15, 1 month, 3, 6 and 12 months
measure: Best Overall Response (BOR) at 1 year
timeFrame: Day 15, 1 month, 3, 6 and 12 months
measure: Progression Free Survival (PFS) at 1 year
timeFrame: Day 15, 1 month, 3, 6 and 12 months
measure: Previous systemic neoadjuvant and adjuvant therapies for RCC prior cabozantinib initiation in terms of nature of the therapy, duration, and reason for discontinuation.
timeFrame: Baseline
measure: First-line therapy for RCC prior cabozantinib initiation in terms of nature of the therapy, duration, and reason for discontinuation.
timeFrame: Baseline
measure: Pattern of use of cabozantinib
timeFrame: Baseline, day 15, 1 month, 3, 6 and 12 months
measure: Quality of life (QoL) change according to Functional Assessment of Cancer Therapy (FKSI-19) questionnaire
timeFrame: Baseline, day 15, 1 month, 3, 6 and 12 months
measure: Pain assessment
timeFrame: Baseline, day 15, 1 month, 3, 6 and 12 months
measure: Subsequent systemic treatment for RCC after cabozantinib discontinuation in terms of the description of the nature of the therapy, starting date.
timeFrame: End of Study visit (12 months if the patient didn't discontinue earlier)
measure: Safety of cabozantinib in the real-world setting
timeFrame: Day 15, 1 month, 3, 6 and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: