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

Cancer Foundation, China400 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Renal Cell Carcinoma

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (2)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Tongji Hospital, Tongji Medical College of Hust

Wuhan, Hubei, China

Outcomes

Primary Outcomes

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.

Time frame: 2008-2011 (up to 3 years)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 2008 - 2011 (up to 3 years)

Data from ClinicalTrials.gov

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