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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)

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ClinicalTrials.gov Identifier: NCT04609800
Recruitment Status : Withdrawn (Unfavorable opinion of IRB/IEC)
First Posted : October 30, 2020
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
Ipsen

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

Condition or disease
Renal Cell Carcinoma

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Estimated Study Start Date : November 6, 2020
Estimated Primary Completion Date : May 10, 2023
Estimated Study Completion Date : May 10, 2023





Primary Outcome Measures :
  1. Overall survival (OS) rate at 1 year after cabozantinib initiation [ Time Frame: up to 12 months ]
    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 Outcome Measures :
  1. Objective Response Rate (ORR) at 1 year [ Time Frame: Day 15, 1 month, 3, 6 and 12 months ]
    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.

  2. Best Overall Response (BOR) at 1 year [ Time Frame: Day 15, 1 month, 3, 6 and 12 months ]
    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.

  3. Progression Free Survival (PFS) at 1 year [ Time Frame: Day 15, 1 month, 3, 6 and 12 months ]
    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.

  4. Previous systemic neoadjuvant and adjuvant therapies for RCC prior cabozantinib initiation in terms of nature of the therapy, duration, and reason for discontinuation. [ Time Frame: Baseline ]
  5. First-line therapy for RCC prior cabozantinib initiation in terms of nature of the therapy, duration, and reason for discontinuation. [ Time Frame: Baseline ]
  6. Pattern of use of cabozantinib [ Time Frame: Baseline, day 15, 1 month, 3, 6 and 12 months ]
    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.

  7. Quality of life (QoL) change according to Functional Assessment of Cancer Therapy (FKSI-19) questionnaire [ Time Frame: Baseline, day 15, 1 month, 3, 6 and 12 months ]
    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.

  8. Pain assessment [ Time Frame: Baseline, day 15, 1 month, 3, 6 and 12 months ]
    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".

  9. Subsequent systemic treatment for RCC after cabozantinib discontinuation in terms of the description of the nature of the therapy, starting date. [ Time Frame: End of Study visit (12 months if the patient didn't discontinue earlier) ]
  10. Safety of cabozantinib in the real-world setting [ Time Frame: Day 15, 1 month, 3, 6 and 12 months ]
    Incidence of Adverse Events (AEs),Serious Adverse Events (SAEs) assessed overall and by intensity and causality.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04609800


Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT04609800    
Other Study ID Numbers: A-FR-60000-070
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020
Keywords provided by Ipsen:
Renal Cell Carcinoma (clear cell or non-clear cell)
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases