Overview

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