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Primary objective: to evaluate whether the addition of sunitinib prolongates the Progression-Free Survival (PFS) in patients with advanced pancreatic cancer receiving first-line gemcitabine chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Gemcitabine + Sunitinib |
|
| B | Other | Gemcitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine + Sunitinib | Drug | Gemcitabine 1.000 mg/m2, d1,8q3weeks Sunitinib 50 mg/day (2weeks on/1weeks off) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression | once all patients completed treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (RR) | once all patients completed treatment | |
| overall survival | at study end | |
| Safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Städtisches Klinikum Braunschweig | Braunschweig | 38114 | Germany | |||
| Universitätsklinikum Essen |
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| Label | URL |
|---|---|
| German Study Description on CESAR's homepage | View source |
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| Gemcitabine | Drug | 1.000 mg/m2 d1,8,15q4weeks |
|
| at study end |
| Essen |
| 45122 |
| Germany |
| Krankenhaus | Frankfurt | 60488 | Germany |
| Klinikum der J. W. Goethe Universität; Zentrum der Inneren Medizin | Frankfurt | 60590 | Germany |
| Internistisches Facharztzentrum | Frankfurt | 60596 | Germany |
| Martin-Luther-Universität Halle-Wittenberg; Medizinische Fakultät | Halle | 06097 | Germany |
| Facharztpraxis | Heidelberg | 69115 | Germany |
| Klinikum Lüdenscheid | Lüdenscheid | 58515 | Germany |
| Klinikum Nürnberg Nord | Nuremberg | 90419 | Germany |
| Robert-Bosch-Krankenhaus | Stuttgart | 70376 | Germany |
| Kantonsspital St. Gallen | Sankt Gallen | 9007 | Switzerland |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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