Renal Cell CarcinomaNCT04637204
Real-world Treatment Patterns and Outcomes Among aRCC Patients on Cabozantinib or Axitinib in England
An observational study of Renal Cell Carcinoma, run by Ipsen at 1 site in United Kingdom.
Trial summary
The present study will aim to describe and understand, in the real-world, the clinical characteristics, treatment patterns and outcomes of advanced renal cell carcinoma (aRCC) patients treated with cabozantinib or axitinib monotherapy in England using the existing data source, Cancer Analysis System (CAS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Cabozantinib and Axitinib
- Type of treatment
- Pill or oral medicine
- How many people
- 1,540 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Nov 2020to 11 Dec 2020
- 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: The study population will include all adult patients diagnosed with aRCC during the study period and identified in the study data source (CAS). The study population will comprise two types of aRCC patients: * Patients who had advanced disease (Stage III/IV) at diagnosis, and * Patients who had non-advanced disease (Stage I/II or missing information on Staging) at diagnosis but advanced at a later date during the study period (proxied by receipt of a SACT treatment indicative of advanced RCC)
Who may be able to join
- Patients with initial renal cancer diagnosis
- Patients diagnosed at Stage III or Stage IV (as defined in CAS): as evidence for advanced/metastatic RCC
- For patients with Stage I/II or patients with missing information on Staging
- Patients who received SACT1 treatment following initial renal cancer diagnosis through end of enrolment (31 July 2019)
- Patients who received cabozantinib or axitinib treatment
Who cannot join
- Diagnosis of concomitant tumour apart from non-melanoma skin cancer in the three years prior to the diagnosis of aRCC
- Less than 18 years of age at the time of initial aRCC diagnosis
- SACT treatment more than 30 days prior to initial aRCC diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Patterns and Outcomes Among Advanced Renal Cell Carcinoma (aRCC) Patients Treated With Cabozantinib or Axitinib Therapy: Non Interventional, Retrospective Study Using Data From Public Health England's Cancer Analysis System
The present study will aim to describe and understand, in the real-world, the clinical characteristics, treatment patterns and outcomes of advanced renal cell carcinoma (aRCC) patients treated with cabozantinib or axitinib monotherapy in England using the existing data source, Cancer Analysis System (CAS).
- Conditions
- Renal Cell Carcinoma
- Being tested
- Cabozantinib, Axitinib
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabozantinibDrug
oral therapy
AxitinibDrug
oral therapy
| Study group | Role | What they receive |
|---|---|---|
| Subgroup 1 | Patients with index treatment: cabozantinib treatment post vascular endothelial growth factor (VEGF)-targeted therapy in any line, except axitinib. Receives: Drug: Cabozantinib | |
| Subgroup 2 | Patients with index treatment: axitinib treatment post VEGF-targeted therapy in any line, except cabozantinib. Receives: Drug: Axitinib | |
| Subgroup 3 | Patients with index treatment: cabozantinib treatment post axitinib by line of therapy (2L, 3L, 3L+) Receives: Drug: Cabozantinib | |
| Subgroup 4 | Patients with index treatment: axitinib treatment post cabozantinib by line of therapy (2L, 3L, 3L+) Receives: Drug: Axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of therapy for the index treatments of interest stratified by line of therapy (LoT)
Duration of therapy will be measured from the initiation of the index treatment until the projected end date of the index treatment (or start of the subsequent therapy). (subgroups 1 to 4)
Measured: From start of index treatment up to the end of treatment or start of subsequent therapy during data collection period (01 January 2011 and 31 January 2020)
Time between subsequent treatment lines
Time gap between the projected end date of the index treatment (cabozantinib or axitinib) until the start of the subsequent treatment. (subgroups 1 to 4)
Measured: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Sequencing of treatments (any treatments received from aRCC diagnosis until the end of follow up or death)
Treatment sequencing will be presented using a Sankey diagram that visualises the regimens received within each line of therapy and the number and percentage of patients who received those particular regimens.
Measured: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Secondary outcomes (12)
Time from aRCC diagnosis to initial SACT initiation
Defined as the time from diagnosis of aRCC until the start date of the first cycle of the SACT regimen (i.e., 1st LoT start). (subgroups 1 to 4)
Measured: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Time from RCC diagnosis to initial SACT initiation
Time from RCC diagnosis to initial SACT initiation will be defined as the time from diagnosis of RCC until the start date of the first cycle of the SACT regimen. (subgroups 1 to 4)
Measured: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Time from RCC diagnosis to treatment initiation of cabozantinib
Time from diagnosis of RCC until the start of the first prescription of cabozantinib. (subgroups 1 and 3)
Measured: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Time from RCC diagnosis to treatment initiation of axitinib
Time from diagnosis of RCC until the start of the prescription of axitinib.
Measured: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Time from aRCC diagnosis to treatment initiation of cabozantinib
Time from diagnosis of aRCC until the start of the first prescription of cabozantinib. (subgroups 1 and 3)
Measured: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Time from aRCC diagnosis to treatment initiation of axitinib
Time from diagnosis of aRCC until the start of the first prescription of axitinib. (subgroups 2 and 4)
Measured: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Overall survival (OS)
Time from start of index treatment (cabozantinib/axitinib) until the date of death (from any cause) during the study period. (subgroups 1 to 4)
Measured: From start of index treatment until death or end of data collection period (01 January 2011 and 31 January 2020 whichever occurs first
Landmark survival
Landmark survival will be defined as the time from start of the index treatment until date of death (from any cause) at specific time points (12, 18, and 24 months). (subgroups 1 to 4)
Measured: 12 months
Landmark survival
Landmark survival will be defined as the time from start of the index treatment until date of death (from any cause) at specific time points (12, 18, and 24 months). (subgroups 1 to 4)
Measured: 18 months
Landmark survival
Landmark survival will be defined as the time from start of the index treatment until date of death (from any cause) at specific time points (12, 18, and 24 months). (subgroups 1 to 4)
Measured: 24 months
Time to next treatment (or death) (TTNT)
Time to next treatment (or death) (TTNT) will be defined as the time from start of index treatment until the start of the subsequent LoT (subgroups 1 to 4)
Measured: From start of index treatment until the start of subsequent therapy during data collection period (01 January 2011 and 31 January 2020)
Time to treatment discontinuation (TTTD)
Time to treatment discontinuation (TTTD) will be defined as time from treatment initiation until treatment discontinuation or death. (subgroups 1 to 4)
Measured: From start of index treatment until discontinuation or death during data collection period (01 January 2011 and 31 January 2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start24 Nov 2020
- Primary completion11 Dec 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 1,540 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
- NCT04637204
- Sponsor's protocol ID
- CLIN-60000-450
- Status last verified
- Jan 2021
- First submitted
- 12 Nov 2020
- Last updated
- 1 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
Publications
Brown J, Harrow B, Marciniak A, McCarthy C, Houchard A, Cirneanu L, Protheroe A. Cabozantinib and Axitinib After Vascular Endothelial Growth Factor Therapy in Patients with Advanced Renal Cell Carcinoma: A Retrospective Cohort Study from England. Drugs Real World Outcomes. 2024 Jun;11(2):195-207. doi: 10.1007/s40801-023-00415-w. Epub 2024 Jan 24.
PubMed 38265633
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns and Outcomes Among Advanced Renal Cell Carcinoma (aRCC) Patients Treated With Cabozantinib or Axitinib Therapy: Non Interventional, Retrospective Study Using Data From Public Health England's Cancer Analysis System
- ClinicalTrials.gov ID
- NCT04637204
- Acronym / sponsor ID
- CLIN-60000-450
- Conditions
- Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,540 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 19 Nov 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 present study will aim to describe and understand, in the real-world, the clinical characteristics, treatment patterns and outcomes of advanced renal cell carcinoma (aRCC) patients treated with cabozantinib or axitinib monotherapy in England using the existing data source, Cancer Analysis System (CAS).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subgroup 1 | – | Drug: CabozantinibPatients with index treatment: cabozantinib treatment post vascular endothelial growth factor (VEGF)-targeted therapy in any line, except axitinib. |
| Subgroup 2 | – | Drug: AxitinibPatients with index treatment: axitinib treatment post VEGF-targeted therapy in any line, except cabozantinib. |
| Subgroup 3 | – | Drug: CabozantinibPatients with index treatment: cabozantinib treatment post axitinib by line of therapy (2L, 3L, 3L+) |
| Subgroup 4 | – | Drug: AxitinibPatients with index treatment: axitinib treatment post cabozantinib by line of therapy (2L, 3L, 3L+) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include all adult patients diagnosed with aRCC during the study period and identified in the study data source (CAS). The study population will comprise two types of aRCC patients: * Patients who had advanced disease (Stage III/IV) at diagnosis, and * Patients who had non-advanced disease (Stage I/II or missing information on Staging) at diagnosis but advanced at a later date during the study period (proxied by receipt of a SACT treatment indicative of advanced RCC)
Key inclusion criteria (5 listed)
- Patients with initial renal cancer diagnosis
- Patients diagnosed at Stage III or Stage IV (as defined in CAS): as evidence for advanced/metastatic RCC
- For patients with Stage I/II or patients with missing information on Staging
- Patients who received SACT1 treatment following initial renal cancer diagnosis through end of enrolment (31 July 2019)
- Patients who received cabozantinib or axitinib treatment
Key exclusion criteria (3 listed)
- Diagnosis of concomitant tumour apart from non-melanoma skin cancer in the three years prior to the diagnosis of aRCC
- Less than 18 years of age at the time of initial aRCC diagnosis
- SACT treatment more than 30 days prior to initial aRCC diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabozantiniboral therapy | Drug | Subgroup 1, Subgroup 3 |
| Axitiniboral therapy | Drug | Subgroup 2, Subgroup 4 |
Primary outcome
Duration of therapy for the index treatments of interest stratified by line of therapy (LoT)
Time frame: From start of index treatment up to the end of treatment or start of subsequent therapy during data collection period (01 January 2011 and 31 January 2020)
Duration of therapy will be measured from the initiation of the index treatment until the projected end date of the index treatment (or start of the subsequent therapy). (subgroups 1 to 4)
Time between subsequent treatment lines
Time frame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Time gap between the projected end date of the index treatment (cabozantinib or axitinib) until the start of the subsequent treatment. (subgroups 1 to 4)
Sequencing of treatments (any treatments received from aRCC diagnosis until the end of follow up or death)
Time frame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Treatment sequencing will be presented using a Sankey diagram that visualises the regimens received within each line of therapy and the number and percentage of patients who received those particular regimens.
12 secondary outcomes
Time from aRCC diagnosis to initial SACT initiation
Time frame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Time from RCC diagnosis to initial SACT initiation
Time frame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Time from RCC diagnosis to treatment initiation of cabozantinib
Time frame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Time from RCC diagnosis to treatment initiation of axitinib
Time frame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Time from aRCC diagnosis to treatment initiation of cabozantinib
Time frame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Time from aRCC diagnosis to treatment initiation of axitinib
Time frame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Overall survival (OS)
Time frame: From start of index treatment until death or end of data collection period (01 January 2011 and 31 January 2020 whichever occurs first
Landmark survival
Time frame: 12 months
Landmark survival
Time frame: 18 months
Landmark survival
Time frame: 24 months
Time to next treatment (or death) (TTNT)
Time frame: From start of index treatment until the start of subsequent therapy during data collection period (01 January 2011 and 31 January 2020)
Time to treatment discontinuation (TTTD)
Time frame: From start of index treatment until discontinuation or death during data collection period (01 January 2011 and 31 January 2020)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Derived from this study: PubMed 38265633Brown J, Harrow B, Marciniak A, McCarthy C, Houchard A, Cirneanu L, Protheroe A. Cabozantinib and Axitinib After Vascular Endothelial Growth Factor Therapy in Patients with Advanced Renal Cell Carcinoma: A Retrospective Cohort Study from England. Drugs Real World Outcomes. 2024 Jun;11(2):195-207. doi: 10.1007/s40801-023-00415-w. Epub 2024 Jan 24.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Ipsen at 1 site in United Kingdom.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of therapy for the index treatments of interest stratified by line of therapy (LoT) (time frame: From start of index treatment up to the end of treatment or start of subsequent therapy during data collection period (01 January 2011 and 31 January 2020)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04637204, which also lists 1 linked publication.
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 1 Feb 2021.