Clinical trial NCT04637204: Real-world Treatment Patterns and Outcomes Among aRCC Patients on Cabozantinib or Axitinib in England
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 1540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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)

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Duration of therapy for the index treatments of interest stratified by line of therapy (LoT)
timeFrame: 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)
measure: Time between subsequent treatment lines
timeFrame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
measure: Sequencing of treatments (any treatments received from aRCC diagnosis until the end of follow up or death)
timeFrame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Secondary outcomes:
measure: Time from aRCC diagnosis to initial SACT initiation
timeFrame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
measure: Time from RCC diagnosis to initial SACT initiation
timeFrame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
measure: Time from RCC diagnosis to treatment initiation of cabozantinib
timeFrame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
measure: Time from RCC diagnosis to treatment initiation of axitinib
timeFrame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
measure: Time from aRCC diagnosis to treatment initiation of cabozantinib
timeFrame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
measure: Time from aRCC diagnosis to treatment initiation of axitinib
timeFrame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
measure: Overall survival (OS)
timeFrame: From start of index treatment until death or end of data collection period (01 January 2011 and 31 January 2020 whichever occurs first
measure: Landmark survival
timeFrame: 12 months
measure: Landmark survival
timeFrame: 18 months
measure: Landmark survival
timeFrame: 24 months
measure: Time to next treatment (or death) (TTNT)
timeFrame: From start of index treatment until the start of subsequent therapy during data collection period (01 January 2011 and 31 January 2020)
measure: Time to treatment discontinuation (TTTD)
timeFrame: From start of index treatment until discontinuation or death during data collection period (01 January 2011 and 31 January 2020)
Other outcomes:
Locations:
city: Slough
country: United Kingdom
facility: Ipsen Facility
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: