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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006097-76 | EudraCT Number |
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difficulty enrollment, no patients received treatment
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| Name | Class |
|---|---|
| Federico II University | OTHER |
| University of Campania Luigi Vanvitelli | OTHER |
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The purpose of this study is to verify if adding a locoregional treatment of liver metastasis (with trans-arterial embolization-TAE) to medical treatments of proven efficacy can prolong the progression free survival of patients affected by neuroendocrine tumors (NET) with inoperable liver metastases
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacologic therapy | Active Comparator | Patients in this arm receive systemic pharmacologic therapy alone |
|
| TAE and pharmacologic therapy | Experimental | Patients in this arm receive systemic pharmacologic therapy and TAE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| approved pharmacologic therapy | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | two years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 3 years | |
| number of objective responses | measured at 3 months and 6 months | |
| changes in quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| exploratory analysis of prognostic factors | clinical factors will be explored in relation to patient outcomes | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A Colao, M.D. | Federico II University | Principal Investigator |
| A Faggiano, M.D. | Federico II University | Principal Investigator |
| R D'Angelo, M.D. | NCI Naples | Principal Investigator |
| F Fiore, MD | NCI Naples | Principal Investigator |
| F Perrone, MD | NCI Naples | Principal Investigator |
| C Gallo, MD | University of Campania Luigi Vanvitelli | Principal Investigator |
| MC Piccirillo, MD | NCI Naples | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albano Laziale Ospedale "Regina Apoltolorum" | Albano Laziale | Italy | ||||
| Università di Ferrara |
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| TAE | Procedure | after randomization, and after 3 months |
|
|
| up to 6 months |
| worst grade adverse event per patient | 6 months |
| Ferrara |
| Italy |
| Università di Genova | Genova | Italy |
| Istituto Europeo di Oncologia | Milan | Italy |
| Istituto Nazionale Tumori | Milan | Italy |
| Ospedale San Raffaele | Milan | Italy |
| Istituto Nazionale dei Tumori | Naples | Italy |
| Ospedale Cardarelli | Naples | Italy |
| Presidio Monaldi - AORN Ospedale dei Colli | Naples | Italy |
| Istituto Regina Elena | Roma | Italy |
| Azienda Ospedaliero-Universitaria S.M. della Misericordia di Udine | Udine | Italy |
| Università di Verona Policlinico GB Rossi | Verona | Italy |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D013004 | Somatostatin |
| ID | Term |
|---|---|
| D010905 | Pituitary Hormone Release Inhibiting Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010187 | Pancreatic Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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