Systemic Therapy With or Without Upfront Transarterial Embolization for Inoperable Liver Metastasis of Neuroendocrine Tumors

Phase 3

Terminated

• Conditions: Neuroendocrine Tumors
• Interventions: Drug: approved pharmacologic therapy; Procedure: TAE

• Registration Number: NCT01755182
• Lead Sponsor: National Cancer Institute, Naples

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-24
• Study Start: 2013-07
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-05
• Last Update Posted: 2016-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacologic therapy	approved pharmacologic therapy	Patients in this arm receive systemic pharmacologic therapy alone
TAE and pharmacologic therapy	approved pharmacologic therapy	Patients in this arm receive systemic pharmacologic therapy and TAE
TAE and pharmacologic therapy	TAE	Patients in this arm receive systemic pharmacologic therapy and TAE

Primary Outcome Measures

Name	Time	Method
progression free survival	two years

Secondary Outcome Measures

Name	Time	Method
overall survival	3 years
number of objective responses	measured at 3 months and 6 months
changes in quality of life	up to 6 months
worst grade adverse event per patient	6 months

Trial Locations

Locations (12)

Albano Laziale Ospedale "Regina Apoltolorum"; 🇮🇹 Albano Laziale, Italy

Istituto Nazionale Tumori; 🇮🇹 Milano, Italy

Istituto Europeo di Oncologia; 🇮🇹 Milano, Italy

Ospedale San Raffaele; 🇮🇹 MIlano, Italy

Università di Ferrara; 🇮🇹 Ferrara, Italy

Università di Genova; 🇮🇹 Genova, Italy

Presidio Monaldi - AORN Ospedale dei Colli; 🇮🇹 Napoli, Italy

Università di Verona Policlinico GB Rossi; 🇮🇹 Verona, Italy

Istituto Nazionale dei Tumori; 🇮🇹 Napoli, Italy

Ospedale Cardarelli; 🇮🇹 Napoli, Italy

Azienda Ospedaliero-Universitaria S.M. della Misericordia di Udine; 🇮🇹 Udine, Italy

Istituto Regina Elena; 🇮🇹 Roma, Italy