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

Completed

• Conditions: Renal Cell Carcinoma

• Registration Number: NCT01441661
• Lead Sponsor: Cancer Foundation, China

Brief Summary

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

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 Timeline

• Status Verified: 2007-09
• Study Start: 2007-11
• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-28
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2013-03-15
• Last Update Posted: 2013-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	2008-2011 (up to 3 years)	* 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.

Secondary Outcome Measures

Name	Time	Method
Progression Free survival (PFS)	2008 - 2011 (up to 3 years)	• 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.
Overall Survival (OS)	2008 - 2011 (up to 3 years)	• 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.
Number of patients with adverse events	2008 - 2011 (up to 3 years)	• 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.

Trial Locations

Locations (2)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Tongji Hospital, Tongji Medical College of Hust; 🇨🇳 Wuhan, Hubei, China