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

NCT01755182 | Terminated Phase 3

• 2 other identifiers: LOTUS2011-006097-76
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 12

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

Conditions

Neuroendocrine Tumors

Keywords

locoregional treatment; liver metastases; transarterial embolization; upfront treatment; inoperable; octreotide; gastroenteropancreatic (GEP)primary; pulmonary primary; primary unknown origin; systemic therapy

Outcome Measures

Primary Outcomes (1)

• progression free survival

  two years

Secondary Outcomes (4)

• 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

Other Outcomes (1)

• exploratory analysis of prognostic factors

  3 years

Study Arms (2)

Pharmacologic therapy

ACTIVE COMPARATOR

Patients in this arm receive systemic pharmacologic therapy alone

Drug: approved pharmacologic therapy

TAE and pharmacologic therapy

EXPERIMENTAL

Patients in this arm receive systemic pharmacologic therapy and TAE

Drug: approved pharmacologic therapy; Procedure: TAE

Interventions

approved pharmacologic therapy DRUG

Also known as: somatostatin analog or other medicine with proven efficacy

Pharmacologic therapy; TAE and pharmacologic therapy

TAE PROCEDURE

after randomization, and after 3 months

Also known as: transarterial embolization

TAE and pharmacologic therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous loco-regional post-surgical treatment
• Poorly differentiated histology
• Extrahepatic metastasis in critical locations as: brain, spinal cord, lung with respiratory impairment, symptomatic vertebral lesions
• Patients with only extra-hepatic lesions

Sponsors & Collaborators

• National Cancer Institute, Naples: lead
• Federico II University: collaborator
• University of Campania Luigi Vanvitelli: collaborator

Study Sites (12)

Albano Laziale Ospedale "Regina Apoltolorum"

Albano Laziale, Italy

Location

Università di Ferrara

Ferrara, Italy

Location

Università di Genova

Genova, Italy

Location

Istituto Europeo di Oncologia

Milan, Italy

Location

Istituto Nazionale Tumori

Milan, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

Istituto Nazionale dei Tumori

Napoli, Italy

Location

Ospedale Cardarelli

Napoli, Italy

Location

Presidio Monaldi - AORN Ospedale dei Colli

Napoli, Italy

Location

Istituto Regina Elena

Roma, Italy

Location

Azienda Ospedaliero-Universitaria S.M. della Misericordia di Udine

Udine, Italy

Location

Università di Verona Policlinico GB Rossi

Verona, Italy

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Somatostatin

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• A Colao, M.D.

  Federico II University

  PRINCIPAL INVESTIGATOR

• A Faggiano, M.D.

  Federico II University

  PRINCIPAL INVESTIGATOR

• R D'Angelo, M.D.

  NCI Naples

  PRINCIPAL INVESTIGATOR

• F Fiore, MD

  NCI Naples

  PRINCIPAL INVESTIGATOR

• F Perrone, MD

  NCI Naples

  PRINCIPAL INVESTIGATOR

• C Gallo, MD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

• MC Piccirillo, MD

  NCI Naples

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 24, 2012
• Study Start: July 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 6, 2016

Record last verified: 2016-05

Locations

IT (12)