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

• Status: Terminated
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Collaborators: Federico II University; Second University of Naples; University of Campania "Luigi Vanvitelli"
• Treatments: Somatostatin

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