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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01755182
Recruitment Status : Terminated (difficulty enrollment, no patients received treatment)
First Posted : December 24, 2012
Last Update Posted : May 6, 2016
Federico II University
University of Campania "Luigi Vanvitelli"
Information provided by (Responsible Party):
National Cancer Institute, Naples

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

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: approved pharmacologic therapy Procedure: TAE Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : July 2013
Primary Completion Date : March 2016
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

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

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

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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
University of Campania "Luigi Vanvitelli"
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

Responsible Party: National Cancer Institute, Naples Identifier: NCT01755182     History of Changes
Other Study ID Numbers: LOTUS
2011-006097-76 ( EudraCT Number )
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: May 6, 2016
Last Verified: May 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
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
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs