Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma
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.
Renal Cell Carcinoma
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma: a Multicenter, Non-interventional, Retrospective Survey|
- Disease control rate (DCR) [ Time Frame: 2008-2011 (up to 3 years) ] [ Designated as safety issue: No ]
- 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.
- Progression Free survival (PFS) [ Time Frame: 2008 - 2011 (up to 3 years) ] [ Designated as safety issue: No ]• 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) [ Time Frame: 2008 - 2011 (up to 3 years) ] [ Designated as safety issue: No ]• 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 [ Time Frame: 2008 - 2011 (up to 3 years) ] [ Designated as safety issue: Yes ]• 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.
|Study Start Date:||November 2007|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Sunitinib Renal Cell Carcinoma
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441661
|Cancer Institute and Hospital, Chinese Academy of Medical Sciences|
|Beijing, Beijing, China, 100021|
|Tongji Hospital, Tongji Medical College of Hust|
|Wuhan, Hubei, China, 430030|
|Principal Investigator:||Zhangqun Ye, MD||Tongji Hospital|