Skip to main content
OpenTrials
Completed

NCT Number: NCT04637204

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ipsen Facility

Slough, Sl1 3XE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cabozantinib

Drug

oral therapy

Axitinib

Drug

oral therapy

Primary outcomes

  1. 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)

  2. 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)

  3. 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.

Secondary outcomes

  1. 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)

    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)

  2. 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 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)

  3. 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 diagnosis of RCC until the start of the first prescription of cabozantinib. (subgroups 1 and 3)

  4. 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 diagnosis of RCC until the start of the prescription of axitinib.

  5. 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 diagnosis of aRCC until the start of the first prescription of cabozantinib. (subgroups 1 and 3)

  6. 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)

    Time from diagnosis of aRCC until the start of the first prescription of axitinib. (subgroups 2 and 4)

  7. 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

    Time from start of index treatment (cabozantinib/axitinib) until the date of death (from any cause) during the study period. (subgroups 1 to 4)

  8. Landmark survival

    Time frame: 12 months

    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)

  9. Landmark survival

    Time frame: 18 months

    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)

  10. Landmark survival

    Time frame: 24 months

    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)

  11. 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 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)

  12. 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)

    Time to treatment discontinuation (TTTD) will be defined as time from treatment initiation until treatment discontinuation or death. (subgroups 1 to 4)

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 19, 2020
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.