Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT01441661|
Recruitment Status : Completed
First Posted : September 28, 2011
Last Update Posted : March 18, 2013
|Condition or disease|
|Renal Cell Carcinoma|
|Study Type :||Observational|
|Actual Enrollment :||400 participants|
|Official Title:||Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma: a Multicenter, Non-interventional, Retrospective Survey|
|Study Start Date :||November 2007|
|Primary Completion Date :||June 2012|
|Study Completion Date :||June 2012|
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.
- Disease control rate (DCR) [ Time Frame: 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.
- Progression Free survival (PFS) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|