Systemic Therapy With or Without Upfront Transarterial Embolization for Inoperable Liver Metastasis of Neuroendocrine Tumors
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
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: approved pharmacologic therapy Type: Drug
Name: TAE Type: Procedure
Overall Status
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
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
National Cancer Institute, Naples
National Cancer Institute, Naples
Record processing date processed this data on July 28, 2015 page