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| Name | Class |
|---|---|
| Samsung Medical Center | OTHER |
| Seoul National University Hospital | OTHER |
| Kyungpook National University Hospital | OTHER |
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To evaluate the efficacy and safety of sunitinib in non-clear cell type renal cell carcinoma with the exception of pure sarcomatoid carcinoma and collecting duct carcinoma
There have been no standard treatment in non-clear cell renal cell carcinoma. Retrospective studies showed sunitinib or sorafenib might be active in non-clear cell renal cell carcinoma, especially papillary type and chromophobe type.
This study is to evaluate efficacy and safety of sunitinib in this group of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunitinib | Experimental | Sunitinib 50 mg D1-D28 every 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib | Drug | Sunitinib 50 mg D1-D28 every 6 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Tumor response is to be measured every 6 weeks. RECIST v.1.1 will be used to definte target lesion and non-target lesion and classify the response category. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Form the date of enrollment to the date of the first documented disease progression or death from any cause, which came first. | up to 24 months |
| overall survival | up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Lyun Lee, MD, PhD | Asan Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22228449 | Derived | Lee JL, Ahn JH, Lim HY, Park SH, Lee SH, Kim TM, Lee DH, Cho YM, Song C, Hong JH, Kim CS, Ahn H. Multicenter phase II study of sunitinib in patients with non-clear cell renal cell carcinoma. Ann Oncol. 2012 Aug;23(8):2108-2114. doi: 10.1093/annonc/mdr586. Epub 2012 Jan 6. |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Safety | Safety will be assessed using CTCAE v.3.0 | up to 24 months |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |