Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma

Study Overview
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Brief Summary
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This non-interventional study includes patients with advanced renal cell carcinoma who are treated with Sunitinib alone or combined with other systemic therapies. The aim of the trial is to increase knowledge about usage, dosage, efficacy and safety under conditions of routine use of Sunitinib.

Detailed Description
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Because State Food and Drug Administration (SFDA) exempted manufacturers from conducting clinical trials of Sunitinib in China, overall efficacy and safety data of Sunitinib in Chinese patients with renal cell carcinoma were deficiency. The investigators carried out this research project will be sufficient evidence, and help clinicians in China to make decision in real daily practice.

Official Title
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Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma: a Multicenter, Non-interventional, Retrospective Survey

Conditions
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Renal Cell Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed, unresectable advanced renal cell carcinoma; Sunitinib as first-line treatment alone or combined with other therapies. Exclusion Criteria: History of Grade 3/4 severe allergic reaction to Sunitinib or its metabolites
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sunitinib Renal Cell Carcinoma<br>Patients diagnosed with Renal Cell Carcinoma (RCC) and treated with Sunitinib from 2008 to present will be eligible. This will include current active patients as well as patients who have expired and have medical records available. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate (DCR) | To determine the Disease control rate (DCR) defined as the percentage of patients who have a partial response (CR) or complete response (PR) to Sunitinib plus those whose disease is stable (DS). To determine the Objective Responsive Rate (ORR) defined as the percentage of patients who have a partial response (PR) or complete response (CR) to Sunitinib. | 2008-2011 (up to 3 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free survival (PFS) | • To assess the Progression Free survival (PFS) as defined by time interval from date of first dose of Sunitinib to date of the progression of cancer or date of death due to any reasons whichever appears earlier. | 2008 - 2011 (up to 3 years) | 
| Overall Survival (OS) | • To evaluate Overall Survival (OS) as defined by time interval from date of first dose of Sunitinib to date of death due to any reason. | 2008 - 2011 (up to 3 years) | 
| Number of patients with adverse events | • To evaluate Safety of Sunitinib. Adverse events were graded according to the National Cancer Institute issued the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. | 2008 - 2011 (up to 3 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sunitinib, kidney diseases, urogenital neoplasms, kidney cancer