RANDOMIZED PHASE 3 TRIAL EVALUATING THE EFFICACY OF LOCOREGIONAL TREATMENT WITH TRANSARTERIAL EMBOLIZATION (TAE) FOR LIVER METASTASIS, IN COMBINATION WITH OCTREOTIDE LAR, IN PATIENTS WITH NEUROENDOCRINE TUMOR AND INOPERABLE LIVER METASTASIS.

• Conditions: PATIENTS WITH NEUROENDOCRINE TUMOR AND INOPERABLE LIVER METASTASIS; MedDRA version: 14.1Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-006097-76-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-08
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Diagnosis of gatroenteropancreatic (GEP), pulmonary or unknown primary NET
2.Unresectable liver metastases, according the judgment of surgeon, (the reasons for the opinion of surgeon should be made explicit)
3.Hepatic involvement =50% volume of the organ
4.Well (G1) or medium (G2) differentiated histology (according to WHO 2010 classification)
5.Ki67 = 20% (G1-G2)
6.Life expectancy > 6 months
7.Age = 18 and < 80 years

9.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 tumor, that doesn’t need of a symptomatic therapy with analogues of somatostatin [insulinoma, gastrinoma, ACTHoma], it is necessary to wait for radiological progression)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Previous loco-regional postsurgical treatment
2.Low differentiated histology
3.Severe concomitant morbidities such as: severe coagulopathy (to be detailed), 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
4.Extrahepatic metastasis in critical locations as: brain, spinal cord, lung with respiratory impairment, symptomatic vertebral lesions
5.Patients with progression disease only on the extra-hepatic localizations during screening phase
6.Patients with progression disease on critical location such as: brain, spinal cord, lung with respiratory impairment, symptomatic vertebral lesions

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified