Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007609-36 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital, Essen | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim ist to identify biomarkers in the blood, to indicate early response or early treatment resistance.
Prospective randomized multi-center Phase II trial for resection of metastases from pulmonary metastases (poor prognosis) in clear cell renal cell carcinoma + / - adjuvant sunitinib therapy over one year
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunitinib | Active Comparator | one year adjuvant treatment with sunitinib |
|
| Placebo | Placebo Comparator | one year treatment with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib | Drug | one-year adjuvant Treatment with Sunitinib, schematic (4:2): 4 weeks (28) 50 mg(milligram) daily, 2 weeks (14) break |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2 year relapse-free survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| perioperative mortality and morbidity | 5 years | |
| Side effect of adjuvant therapy | 5 years | |
| Quality of Life of the Patient |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susanne Krege, Priv. Doz. Dr. med. | Contact | 02 151 / 334-23 81 |
| Name | Affiliation | Role |
|---|---|---|
| Susanne Krege, Priv. Doz. Dr. med. | urological hospital of Maria Hilf Krankenhaus Krefeld | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsmedizin Charité Berlin | Not yet recruiting | Berlin | 10117 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | one-year Treatment, schematic (4:2): 4 weeks (28) 50 mg(milligram) daily, 2 weeks (14) break, |
|
|
| 5 years |
| Overall Survival | 5 years |
| Franziskus Krankenhaus | Not yet recruiting | Berlin | 10787 | Germany |
|
| Helios Klinikum Emil von Behring | Not yet recruiting | Berlin | 14165 | Germany |
|
| university hospital of Düsseldorf | Recruiting | Düsseldorf | 40255 | Germany |
|
| university hospital of Essen | Recruiting | Essen | 45122 | Germany |
|
| Ruhrlandklinik Department of Thoracic Surgery | Not yet recruiting | Essen | 45239 | Germany |
|
| university hospital of Freiburg | Recruiting | Freiburg im Breisgau | 79106 | Germany |
|
| university Hospital of Heidelberg | Recruiting | Heidelberg | 69119 | Germany |
|
| urological hospital of Maria Hilf Krankenhaus Krefeld | Recruiting | Krefeld | 47805 | Germany |
|
| Hospital of Großhadern | Not yet recruiting | München | 81377 | Germany |
|
| Dr.-Horst-Schmidt-Kliniken GmbH | Recruiting | Wiesbaden | 65199 | Germany |
|
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D002277 | Carcinoma |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| 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 |
Not provided
Not provided
| 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 |
Not provided
Not provided