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

May 5, 2016 updated by: National Cancer Institute, Naples

Randomized Phase 3 Trial Evaluating the Efficacy of Locoregional Treatment With Transarterial Embolization (TAE) for Liver Metastases, in Combination With Pharmacotherapy, in Patients With Neuroendocrine Tumor and Inoperable Liver Metastasis.

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

Study Overview

Status

Terminated

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Albano Laziale, Italy
        • Albano Laziale Ospedale "Regina Apoltolorum"
      • Ferrara, Italy
        • Università di Ferrara
      • Genova, Italy
        • Universita di Genova
      • MIlano, Italy
        • Ospedale San Raffaele
      • Milano, Italy
        • Istituto Europeo di Oncologia
      • Milano, Italy
        • Istituto Nazionale Tumori
      • Napoli, Italy
        • Istituto Nazionale dei Tumori
      • Napoli, Italy
        • Ospedale Cardarelli
      • Napoli, Italy
        • Presidio Monaldi - AORN Ospedale dei Colli
      • Roma, Italy
        • Istituto Regina Elena
      • Udine, Italy
        • Azienda Ospedaliero-Universitaria S.M. della Misericordia di Udine
      • Verona, Italy
        • Università di Verona Policlinico GB Rossi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pharmacologic therapy
Patients in this arm receive systemic pharmacologic therapy alone
Other Names:
  • somatostatin analog or other medicine with proven efficacy
Experimental: TAE and pharmacologic therapy
Patients in this arm receive systemic pharmacologic therapy and TAE
Other Names:
  • somatostatin analog or other medicine with proven efficacy
after randomization, and after 3 months
Other Names:
  • transarterial embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 3 years
3 years
number of objective responses
Time Frame: measured at 3 months and 6 months
measured at 3 months and 6 months
changes in quality of life
Time Frame: up to 6 months
up to 6 months
worst grade adverse event per patient
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
exploratory analysis of prognostic factors
Time Frame: 3 years
clinical factors will be explored in relation to patient outcomes
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

December 18, 2012

First Posted (Estimate)

December 24, 2012

Study Record Updates

Last Update Posted (Estimate)

May 6, 2016

Last Update Submitted That Met QC Criteria

May 5, 2016

Last Verified

May 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neuroendocrine Tumors

Clinical Trials on approved pharmacologic therapy

Subscribe