Real-world Treatment Patterns and Outcomes Among aRCC Patients on Cabozantinib or Axitinib in England

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637204
• Other study ID #: CLIN-60000-450
• Status: Completed
• Start date: November 24, 2020
• Est. completion date: December 11, 2020

Study information

• Verified date: January 2021
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1540
• Est. completion date: December 11, 2020
• Est. primary completion date: December 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• Cabozantinib
oral therapy
• Axitinib
oral therapy

Locations

Country	Name	City	State
United Kingdom	Ipsen Facility	Slough

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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)
Primary	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)	From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Primary	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.	From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Secondary	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)	From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Secondary	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)	From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Secondary	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)	From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Secondary	Time from RCC diagnosis to treatment initiation of axitinib	Time from diagnosis of RCC until the start of the prescription of axitinib.	From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Secondary	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)	From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Secondary	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)	From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Secondary	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)	From start of index treatment until death or end of data collection period (01 January 2011 and 31 January 2020 whichever occurs first
Secondary	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)	12 months
Secondary	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)	18 months
Secondary	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)	24 months
Secondary	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)	From start of index treatment until the start of subsequent therapy during data collection period (01 January 2011 and 31 January 2020)
Secondary	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)	From start of index treatment until discontinuation or death during data collection period (01 January 2011 and 31 January 2020)