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

This study has been terminated.
(difficulty enrollment, no patients received treatment)
Federico II University
Second University of Naples
Information provided by (Responsible Party):
National Cancer Institute, Naples Identifier:
First received: December 18, 2012
Last updated: May 5, 2016
Last verified: May 2016
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

Condition Intervention Phase
Neuroendocrine Tumors
Drug: approved pharmacologic therapy
Procedure: TAE
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • progression free survival [ Time Frame: two years ]

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

Other Outcome Measures:
  • exploratory analysis of prognostic factors [ Time Frame: 3 years ]
    clinical factors will be explored in relation to patient outcomes

Enrollment: 1
Study Start Date: July 2013
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pharmacologic therapy
Patients in this arm receive systemic pharmacologic therapy alone
Drug: approved pharmacologic therapy
Other Name: somatostatin analog or other medicine with proven efficacy
Experimental: TAE and pharmacologic therapy
Patients in this arm receive systemic pharmacologic therapy and TAE
Drug: approved pharmacologic therapy
Other Name: somatostatin analog or other medicine with proven efficacy
Procedure: TAE
after randomization, and after 3 months
Other Name: transarterial embolization


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01755182

Albano Laziale Ospedale "Regina Apoltolorum"
Albano Laziale, Italy
Università di Ferrara
Ferrara, Italy
Università di Genova
Genova, Italy
Istituto Europeo di Oncologia
Milano, Italy
Istituto Nazionale Tumori
Milano, Italy
Ospedale San Raffaele
MIlano, Italy
Istituto Nazionale dei Tumori
Napoli, Italy
Ospedale Cardarelli
Napoli, Italy
Presidio Monaldi - AORN Ospedale dei Colli
Napoli, Italy
Istituto Regina Elena
Roma, Italy
Azienda Ospedaliero-Universitaria S.M. della Misericordia di Udine
Udine, Italy
Università di Verona Policlinico GB Rossi
Verona, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Federico II University
Second University of Naples
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 Second University of Naples
Principal Investigator: MC Piccirillo, MD NCI Naples
  More Information

Responsible Party: National Cancer Institute, Naples Identifier: NCT01755182     History of Changes
Other Study ID Numbers: LOTUS
2011-006097-76 ( EudraCT Number )
Study First Received: December 18, 2012
Last Updated: May 5, 2016

Keywords provided by National Cancer Institute, Naples:
locoregional treatment
liver metastases
transarterial embolization
upfront treatment
gastroenteropancreatic (GEP)primary
pulmonary primary
primary unknown origin
systemic therapy

Additional relevant MeSH terms:
Neoplasm Metastasis
Liver Neoplasms
Neuroendocrine Tumors
Carcinoid Tumor
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 25, 2017