Renal Cell CarcinomaCAROLINENCT04609800
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.
An observational study of Renal Cell Carcinoma, run by Ipsen.
Trial summary
The purpose of the protocol is to assess the Overall Survival (OS) at 1 year in patients after cabozantinib initiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2020to 10 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- He/she is already included in an interventional trial with an investigational product at the same time.
About this study
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.
The purpose of the protocol is to assess the Overall Survival (OS) at 1 year in patients after cabozantinib initiation.
- Conditions
- Renal Cell Carcinoma
- Keywords
- Renal Cell Carcinoma (clear cell or non-clear cell)
- Medical subject headings
- Carcinoma, Renal Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
First-line therapy for RCC prior cabozantinib initiation in terms of nature of the therapy, duration, and reason for discontinuation.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: Day 15, 1 month, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start6 Nov 2020 (estimated)
- Primary completion10 May 2023 (estimated)
- Study completion10 May 2023 (estimated)
Why it stopped: Unfavorable opinion of IRB/IEC
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609800
- Sponsor's protocol ID
- A-FR-60000-070
- Acronym
- CAROLINE
- Status last verified
- Dec 2020
- First submitted
- 7 Oct 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04609800
- Acronym / sponsor ID
- CAROLINE / A-FR-60000-070
- Conditions
- Renal Cell Carcinoma
- Keywords
- Renal Cell Carcinoma (clear cell or non-clear cell)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unfavorable opinion of IRB/IEC
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2020 (estimated)
- Primary completion
- 10 May 2023 (estimated)
- Study completion
- 10 May 2023 (estimated)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the protocol is to assess the Overall Survival (OS) at 1 year in patients after cabozantinib initiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- He/she is already included in an interventional trial with an investigational product at the same time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
10 secondary outcomes
Objective Response Rate (ORR) at 1 year
Time frame: Day 15, 1 month, 3, 6 and 12 months
Best Overall Response (BOR) at 1 year
Time frame: Day 15, 1 month, 3, 6 and 12 months
Progression Free Survival (PFS) at 1 year
Time frame: 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.
Time frame: Baseline
First-line therapy for RCC prior cabozantinib initiation in terms of nature of the therapy, duration, and reason for discontinuation.
Time frame: Baseline
Pattern of use of cabozantinib
Time frame: 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
Time frame: Baseline, day 15, 1 month, 3, 6 and 12 months
Pain assessment
Time frame: 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.
Time frame: End of Study visit (12 months if the patient didn't discontinue earlier)
Safety of cabozantinib in the real-world setting
Time frame: Day 15, 1 month, 3, 6 and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
Related trials for Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Ipsen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) rate at 1 year after cabozantinib initiation (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.