An observational study in Renal Cell Carcinoma, sponsored by Cancer Foundation, China. Completed at 2 sites in China. Per ClinicalTrials.gov, last updated 2013-03-18.
Sponsored by Cancer Foundation, China · Observational
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 400 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →This is the only study on the registry with Cancer Foundation, China as lead sponsor.
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Patients diagnosed with 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.
Exclusion Criteria:
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)
* 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)
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)
This study is completed, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.
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