Systemic Therapy With or Without Upfront Transarterial Embolization for Inoperable Liver Metastasis of Neuroendocrine Tumors
Conditions
Neuroendocrine Tumors
Conditions: official terms
Apudoma - Carcinoid Tumor - Neuroendocrine Tumors
Conditions: Keywords
locoregional treatment, liver metastases, transarterial embolization, upfront treatment, inoperable, octreotide, gastroenteropancreatic (GEP)primary, pulmonary primary, primary unknown origin, systemic therapy
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: approved pharmacologic therapy Type: Drug
Name: TAE Type: Procedure
Overall Status
Recruiting
Summary
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Diagnosis of NET of gastroenteropancreatic (GEP), pulmonary or unknown primary site origin

- 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:

- Previous loco-regional post-surgical treatment

- 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
Locations
Albano Laziale Ospedale "Regina Apoltolorum"
Albano Laziale, Italy
Status: Not yet recruiting
Università di Ferrara
Ferrara, Italy
Status: Not yet recruiting
Università di Genova
Genova, Italy
Status: Not yet recruiting
Istituto Europeo di Oncologia
Milano, Italy
Status: Not yet recruiting
Istituto Nazionale Tumori
Milano, Italy
Status: Not yet recruiting
Ospedale San Raffaele
MIlano, Italy
Status: Not yet recruiting
Istituto Nazionale dei Tumori
Napoli, Italy
Status: Recruiting
Istituto Regina Elena
Roma, Italy
Status: Not yet recruiting
Azienda Ospedaliero-Universitaria S.M. della Misericordia di Udine
Udine, Italy
Status: Not yet recruiting
Università di Verona Policlinico GB Rossi
Verona, Italy
Status: Recruiting
Start Date
July 2013
Completion Date
December 2017
Sponsors
National Cancer Institute, Naples
Source
National Cancer Institute, Naples
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page