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)

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.

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

Study Overview

• Status: Withdrawn
• Conditions: Renal Cell Carcinoma

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS) rate at 1 year after cabozantinib initiation	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.	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) at 1 year	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.	Day 15, 1 month, 3, 6 and 12 months
Best Overall Response (BOR) at 1 year	BOR is the best response recorded from the start of the study treatment until the disease progression/recurrence. The BOR will be assessed by tumour response evaluation according to investigator assessment. Tumour response will be evaluated per routine clinical practice by the physician.	Day 15, 1 month, 3, 6 and 12 months
Progression Free Survival (PFS) at 1 year	PFS is defined as the time elapsed from the date of first treatment intake to the date of documented progression reported by the investigator or death due to any cause, whichever occurs first. Disease progression will be assessed by tumour response evaluation according to investigator assessment. Tumour response will be evaluated per routine clinical practice as Progressive / not progressive disease by the physician.	Day 15, 1 month, 3, 6 and 12 months
Previous systemic neoadjuvant and adjuvant therapies for RCC prior cabozantinib initiation in terms of nature of the therapy, duration, and reason for discontinuation.		Baseline
First-line therapy for RCC prior cabozantinib initiation in terms of nature of the therapy, duration, and reason for discontinuation.		Baseline
Pattern of use of cabozantinib	Dose modification, reason of modification and treatment duration of cabozantinib will be described from cabozantinib initiation until participants' end of study treatment or study withdrawal.	Baseline, day 15, 1 month, 3, 6 and 12 months
Quality of life (QoL) change according to Functional Assessment of Cancer Therapy (FKSI-19) questionnaire	QoL change from baseline. The score will be evaluated with FKSI 19 questionnaires at the planned visits and at treatment discontinuation. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms in 4 domains by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.	Baseline, day 15, 1 month, 3, 6 and 12 months
Pain assessment	To assess pain according to the Brief Pain Inventory-Short Form (BPI-SF) questionnaire and analgesic consumption/duration and the time for improvement of symptomatology. BPI-SF has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine".	Baseline, day 15, 1 month, 3, 6 and 12 months
Subsequent systemic treatment for RCC after cabozantinib discontinuation in terms of the description of the nature of the therapy, starting date.		End of Study visit (12 months if the patient didn't discontinue earlier)
Safety of cabozantinib in the real-world setting	Incidence of Adverse Events (AEs),Serious Adverse Events (SAEs) assessed overall and by intensity and causality.	Day 15, 1 month, 3, 6 and 12 months

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Anticipated): November 6, 2020
• Primary Completion (Anticipated): May 10, 2023
• Study Completion (Anticipated): May 10, 2023

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Renal Cell Carcinoma (clear cell or non-clear cell)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: A-FR-60000-070