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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) |
| 2008-2011 (up to 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2008 - 2011 (up to 3 years) |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Zhangqun Ye, MD | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China | ||
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007674 | Kidney Diseases |
| D014565 | Urogenital Neoplasms |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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• 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. |
| 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. | 2008 - 2011 (up to 3 years) |
| Tongji Hospital, Tongji Medical College of Hust |
| Wuhan |
| Hubei |
| 430030 |
| China |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |