Status:
COMPLETED
A Retrospective Medical Record Review of First-Line Sunitinib Administration Schedules and Outcomes Among Patients With mRCC in Latin America (LA)
Lead Sponsor:
Pfizer
Conditions:
Metastatic Renal Cell Carcinoma ( mRCC)
Eligibility:
All Genders
18+ years
Brief Summary
To describe real-world demographic and clinical characteristics, treatment characteristics, and clinical outcomes among patients in Latin America who were treated with first-line sunitinib for metasta...
Detailed Description
Understanding characteristics of patients who switched from a 4/2 to a 2/1 sunitinib schedule or initiated the 2/1 schedule in Brazil, and the resulting clinical outcomes in the real-world setting • ...
Eligibility Criteria
Inclusion
- Diagnosed with metastatic RCC with clear cell histology
- a. The patient may have been initially diagnosed with Stage IV or initially diagnosed at an earlier stage and progressed to having disease at distant sites (i.e., metastatic disease)
- Initiated first-line treatment for metastatic RCC with sunitinib on the 4/2 schedule (all countries) or initiated first-line treatment for metastatic RCC with sunitinib on the 2/1 schedule (Brazil only)
- Switched to the 2/1 schedule (all countries) or initiated the 2/1 schedule (Brazil only) during the first treatment line between January 1, 2014, and June 30, 2018 a. The final dates defining this selection period will be dependent on country-specific ethics and reporting requirements
Exclusion
- 1\. Evidence of other malignant neoplasms (except nonmelanoma skin cancer or carcinoma in situ) within 5 years before switching to the sunitinib 2/1 schedule (all countries) or initiation of the 2/1 schedule (Brazil only)
Key Trial Info
Start Date :
December 13 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 2 2020
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04115189
Start Date
December 13 2019
End Date
December 2 2020
Last Update
May 10 2022
Active Locations (7)
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1
Instituto Médico Especializado Alexander Fleming
Buenos Aires, Argentina
2
Sanatorio del Salvador - Cordoba
Córdoba, Argentina
3
Centro Oncológico de Integración Regional in Mendoza
Mendoza, Argentina, M5500AYB
4
Escola Paulista de Medicina - UNIFESP
São Paulo, Brazil