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To assess the efficacy and safety of RAD001 (everolimus) in non-clear cell renal cell carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAD001 | Experimental | RAD001 10mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAD001 | Drug | RAD001 10mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | It is the time from treatment initiation until disease progression. | 2 months, 4 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | It is the percentage of patients whose cancer shrinks or disappears after treatment. | 2 months, 4 months, 6 months |
| Disease-control rate | It is the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention. |
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Inclusion Criteria:
Histologically or cytologically confirmed non-clear cell renal cell carcinoma (papillary, chromophobe, collecting duct, oncocytic subtype, sarcomatoid mainly)
Subjects with metastatic legion
Subjects aged 18 years or older
Subjects whose ECOG performance status is 0 or 1
Subjects who have laboratory value below; Hematology
Subjects who understand and provide a written informed consent
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23180114 | Derived | Koh Y, Lim HY, Ahn JH, Lee JL, Rha SY, Kim YJ, Kim TM, Lee SH. Phase II trial of everolimus for the treatment of nonclear-cell renal cell carcinoma. Ann Oncol. 2013 Apr;24(4):1026-31. doi: 10.1093/annonc/mds582. Epub 2012 Nov 23. |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| 2 months, 4 months, 6 months |
| Overall survival | The length of time from either the date of diagnosis or the start of treatment for a disease that patients diagnosed with the disease are still alive. | 2 months, 4 months, 6 months |
| Metabolic response rate by FDG-PET | It is assesed target lesions and non- target lesions by FDG-PET. | 2 months, 4 months, 6 months |
| Safety | monthly |
| 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |