Clinical trial NCT04115189: A Retrospective Medical Record Review of First-Line Sunitinib Administration Schedules and Outcomes Among Patients With mRCC in Latin America (LA)
Official title: A Retrospective Medical Record Review of First-Line Sunitinib Administration Schedules and Outcomes Among Patients With Metastatic Renal Cell Carcinoma in Latin America
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Renal Cell Carcinoma ( mRCC)
Keywords: Sunitinib -
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-10-03
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with clear cell mRCC at age 18 or older who initiated sunitinib as first-line treatment between 2014-2018

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

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

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

Eligibility criteria: Inclusion Criteria:

1. 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)
2. 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)
3. 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 Criteria:

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)

Primary outcomes:
measure: Demographic Characteristic of Participants: Year of Birth
timeFrame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Demographic Characteristic of Participants: Comorbidities
timeFrame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Demographic Characteristic of Participants: Primary Health Insurance Type
timeFrame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Demographic Characteristic of Participants: Height
timeFrame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Demographic Characteristic of Participants: Weight
timeFrame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Demographic Characteristic of Participants: Body Mass Index
timeFrame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma
timeFrame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC)
timeFrame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Clinical Characteristic of Participants: Risk Groups
timeFrame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Clinical Characteristic of Participants: Sites of Distant Metastases
timeFrame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: During pre-index period (anytime from initial metastatic diagnosis to before index date), during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis
timeFrame: Before diagnosis of mRCC, anytime during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Duration Between Last Treatment Received and Metastatic Renal Cell Carcinoma (mRCC) Diagnosis
timeFrame: From last treatment received to mRCC diagnosis, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Number of Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC)
timeFrame: From date of metastatic diagnosis to end of data identification period, for a maximum of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Duration of Each Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC)
timeFrame: Duration between initiating and termination date of each treatment line received after mRCC diagnosis, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Duration of Treatment With Sunitinib
timeFrame: Day 1 of sunitinib first line treatment to end date of sunitinib treatment, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Duration Between Discontinuation of 4/2 Schedule and Initiation of 2/1 Schedule
timeFrame: End date of 4/2 sunitinib schedule and start date of 2/1 sunitinib schedule, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Participants With Reasons for Switching to 2/1 Treatment Schedule
timeFrame: Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Duration of Sunitinib 2/1 Treatment Schedule After Switching From 4/2 Treatment Schedule
timeFrame: From index date to end date of 2/1 treatment schedule, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation
timeFrame: From index date to end date of sunitinib 2/1 schedule, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Number of Participants With At-least 1 Dose Change
timeFrame: Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Number of Participants With Reason For Dose Change
timeFrame: Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib
timeFrame: Index date up to end of follow up, disease progression, death, whichever occurred first during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment
timeFrame: Index date, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Adverse Events Observed During First-line Treatment With Sunitinib
timeFrame: Day 1 of sunitinib first line treatment to follow up, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Progression Free Survival (PFS) From Initial Metastatic Diagnosis
timeFrame: From date of mRCC diagnosis to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Progression Free Survival (PFS) From Initiation of Sunitinib 4/2 Treatment Schedule
timeFrame: From date of initiation of sunitinib 4/2 schedule to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Progression Free Survival (PFS) From Initiation of Sunitinib 2/1 Treatment Schedule
timeFrame: From index date to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Overall Survival (OS) From Metastatic Diagnosis
timeFrame: From date of mRCC diagnosis to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Overall Survival (OS) From Initiation of Sunitinib 4/2 Treatment Schedule
timeFrame: From date of mRCC diagnosis to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Overall Survival (OS) From Initiation of Sunitinib 2/1 Treatment Schedule
timeFrame: From date of mRCC diagnosis to date of disease progression, during data identification period of 5 years (data recorded during approximately 12 months of retrospective observation period)
measure: Time to Initiate Second Line Treatment
timeFrame: From mRCC diagnosis to start date of second line treatment and from end date of first line treatment to start date of second line treatment,data identification period of 5 years(data recorded during approx. 12 months of retrospective observation period)
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Instituto Médico Especializado Alexander Fleming
city: Cordoba
country: Argentina
facility: Sanatorio del Salvador - Cordoba
city: Mendoza
country: Argentina
facility: Centro Oncológico de Integración Regional in Mendoza
city: São Paulo
country: Brazil
facility: Escola Paulista de Medicina - UNIFESP
city: Bogotá
country: Colombia
facility: Fundacion Cardiovascular de Colombia
city: Valledupar
country: Colombia
facility: Sociedad de Oncologia y Hematologia Del Cesar ltda (SOHEC)
city: Quito
country: Ecuador
facility: Hospital Eugenio Espejo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: