Randomized Phase 3 Trial Evaluating the Efficacy of Locoregional Treatment With Transarterial Embolization (TAE) for Liver Metastases, in Combination With Octreotide LAR, in Patients With Neuroendocrine Tumor and Inoperable Liver Metastasis.
Inclusion Criteria:
At registration
- 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
- 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
At randomization
- Confirmed criteria as per registration
- Radiological progression of hepatic localizations, verified during screening phase,
or presence of symptoms requiring an immediate treatment with somatostatin analogues
(I.E. in case of a functioning tumour, that doesn't need of a symptomatic therapy
with analogues of somatostatin [insulinoma, gastrinoma, ACTHoma], it is necessary to
wait for radiological progression)
Exclusion Criteria:
At registration
- Previous loco-regional postsurgical treatment
- Low 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
instable 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
At randomization
- Patients with progression of disease only on the extra-hepatic localizations during
screening phase
- Patients with progression disease on critical location such as: brain, spinal cord,
lung with respiratory impairment, symptomatic vertebral lesions