A Retrospective Medical Record Review of First-Line Sunitinib Administration Schedules and Outcomes Among Patients With Metastatic Renal Cell Carcinoma in Latin America

CompletadoClinicalTrials.gov

ID: NCT04115189Tipo: OBSERVATIONALInicio: 13 de dic de 2019Fin estimado: 2 de dic de 2020

Traducción no disponible, mostrando original

Resumen

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 metastatic renal cell carcinoma and switched from the 4/2 to 2/1 administration schedule

Descripción detallada

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 • Describing the occurrence of AEs on the 4/2 and 2/1 schedules

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

\. 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)

Intervenciones

drug

Sunitinib

Patients to receive Sunitinib as first line therapy for mRCC

Ubicaciones

Instituto Médico Especializado Alexander Fleming

Buenos Aires, Argentina

Sanatorio del Salvador - Cordoba

Córdoba, Argentina

Centro Oncológico de Integración Regional in Mendoza

Mendoza, Argentina

Patrocinadores

PrincipalPfizer

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