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This study is to evaluate the efficacy, safety, and feasibility of sunitinib in 4/2 and 2/1 regimen in previously untreated metastatic RCC to select the most promising regimen, which should be used in further studies of this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunitinib 4/2 | Active Comparator | Sunitinib 50 mg PO 4-week on and 2-week off |
|
| Sunitinib 2/1 | Experimental | Sunitinib 50 mg PO 2-week on 1-week off |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib 2/1 | Drug | Sunitinib 50 mg PO 2 weeks followed by 1 week rest |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death) | From the date of randomization to the date of progressive disease, treatment withdrawal, or death from any cause, which came first. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | RECIST v.1.1 will be used to assess tumor responses | 6 months |
| quality of life | EORTC QLQ C30 and EQ5D will be used to assess the quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Lyun Lee, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daegu Catholic University Hospital | Daegu | South Korea | ||||
| Yeungnam University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26347107 | Derived | Lee JL, Kim MK, Park I, Ahn JH, Lee DH, Ryoo HM, Song C, Hong B, Hong JH, Ahn H. RandomizEd phase II trial of Sunitinib four weeks on and two weeks off versus Two weeks on and One week off in metastatic clear-cell type REnal cell carcinoma: RESTORE trial. Ann Oncol. 2015 Nov;26(11):2300-5. doi: 10.1093/annonc/mdv357. Epub 2015 Sep 7. |
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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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| Sunitinib 4/2 |
| Drug |
Sunitinib 50 mg PO 4 weeks followed by 2 week rest |
|
| 12 months |
| Progression free survival | 12 months |
| Overall survival | 36 months |
| Adverse events | CTC AE v.3.0 | about 12 months |
| Daegu |
| South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| 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 |