Systemic Therapy With or Without Upfront Transarterial Embolization for Inoperable Liver Metastasis of Neuroendocrine Tumors
NCT ID: NCT01755182
Last Updated: 2016-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
1 participants
INTERVENTIONAL
2013-07-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pharmacologic therapy
Patients in this arm receive systemic pharmacologic therapy alone
approved pharmacologic therapy
TAE and pharmacologic therapy
Patients in this arm receive systemic pharmacologic therapy and TAE
approved pharmacologic therapy
TAE
after randomization, and after 3 months
Interventions
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approved pharmacologic therapy
TAE
after randomization, and after 3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unresectable liver metastases, according the judgment of surgeon, (the reasons for the opinion of surgeon should be made explicit)
* Hepatic involvement ≤50% volume of the organ
* Radiological evidence of hepatic lesions (contemporaneous progression or appearance of extrahepatic lesions are allowed if not critical sites) that require change or initiation of systemic pharmacotherapy
* Patients undergoing , previously treated , or never treated with systemic medical therapy are eligible
* Patients with or without carcinoid syndrome are eligible
* Well (G1) or medium (G2) differentiated histology (according to WHO 2010 classification)
* Ki67 ≤ 20% (G1-G2)
* Life expectancy \> 6 months
* Age ≥ 18 and \< 80 years
Exclusion Criteria
* Poorly differentiated histology
* Severe concomitant morbidities such as: severe coagulopathy, severe liver failure (to be detailed), renal failure (creatinine \> 2.0 mg/dl) and heart failure (NYHA 3-4 or unstable ischemic heart disease), contraindicating the interventional procedure or influencing the general prognosis (Investigator to provide details of exclusion)
* Extrahepatic metastasis in critical locations as: brain, spinal cord, lung with respiratory impairment, symptomatic vertebral lesions
* Patients with only extra-hepatic lesions
18 Years
80 Years
ALL
No
Sponsors
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Federico II University
OTHER
University of Campania Luigi Vanvitelli
OTHER
National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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A Colao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Federico II University
A Faggiano, M.D.
Role: PRINCIPAL_INVESTIGATOR
Federico II University
R D'Angelo, M.D.
Role: PRINCIPAL_INVESTIGATOR
NCI Naples
F Fiore, MD
Role: PRINCIPAL_INVESTIGATOR
NCI Naples
F Perrone, MD
Role: PRINCIPAL_INVESTIGATOR
NCI Naples
C Gallo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Campania Luigi Vanvitelli
MC Piccirillo, MD
Role: PRINCIPAL_INVESTIGATOR
NCI Naples
Locations
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Albano Laziale Ospedale "Regina Apoltolorum"
Albano Laziale, , Italy
Università di Ferrara
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
Napoli, , Italy
Ospedale Cardarelli
Napoli, , Italy
Presidio Monaldi - AORN Ospedale dei Colli
Napoli, , 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
Countries
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Other Identifiers
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2011-006097-76
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LOTUS
Identifier Type: -
Identifier Source: org_study_id
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