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The purpose of this trial is to determinate the efficacy of Sunitinib in patients with renal cells carcinoma metastasic or locally avanced in patints not candidates to inicial curative nefrectomy.
Study phase II in with one arm in patients with renal cells carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | This study has only one arm with Sunitinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib | Drug | Sunitinib 50mg oral in the morning during 4 weeks with 2 weeks of break. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | every 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Global survival | At last contact date or death date | |
| Response global | Every 12 weeks | |
| Duration of response |
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Inclusion Criteria:
Patients must give their written informed consent before any procedure related to the study is performed.
Patients with renal clear cell carcinoma metastatic or locally advanced, histologically or cytologically documented.The patients with metastasic disease must be not condidated to curative nefrectomy as investigator criteria.
Assessable or measurable disease according to RECIST criteria. The lesions previosly radiated is not considered as target.
Ages equal or superior to 18 years old.
ECOG ≤ 1
Patients with a life expectancy superior to 12 weeks.
Patients with adequate organic function, according to the following criteria:
Patients who are capable of accomplishing the study's requirements and without any impediments to follow the instructions while on study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Luís González Larriba, MD | SOGUG | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital CLINIC | Barcelona | Barcelona | 08036 | Spain | ||
| Hospital Parc Taulí |
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| Every 12 weeks |
| Security and tolerability of Sunitinib | Every 4 weeks |
| Sabadell |
| Barcelona |
| 08208 |
| Spain |
| Hospital Reina Sofía | Córdoba | Córdoba | 14004 | Spain |
| Hospital de Jaén | Jaén | Jaén | 23007 | Spain |
| Hospital Clínico San Carlos | Madrid | Madrid | 28040 | Spain |
| Hospital Central de Asturias | Oviedo | Principality of Asturias | 33006 | Spain |
| Hospital lozano Blesa | Zaragoza | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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