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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by National Cancer Institute, Naples
Sponsor:
Collaborators:
Federico II University
Second University of Naples
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT01755182
First received: December 18, 2012
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to verify if adding a locoregional treatment of liver metastasis (with trans-arterial embolization-TAE) to a medical treatment (with Octreotide LAR and eventually in combination with other 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: Octreotide LAR
Procedure: TAE
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 Octreotide LAR, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • number of objective responses [ Time Frame: measured at 3 months and 6 months ] [ Designated as safety issue: No ]
  • changes in quality of life [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • worst grade adverse event per patient [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • exploratory analysis of prognostic factors [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    clinical factors will be explored in relation to patient outcomes


Estimated Enrollment: 140
Study Start Date: July 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pharmacologic therapy Drug: Octreotide LAR
30 mg IM every 28 days (the addition of other pharmacologic therapies of proven efficacy in NET is permitted)
Experimental: TAE and pharmacologic therapy Drug: Octreotide LAR
30 mg IM every 28 days (the addition of other pharmacologic therapies of proven efficacy in NET is permitted)
Procedure: TAE
after randomization, and after 3 months
Other Name: transarterial embolization

Detailed Description:

NET patients with unresectable hepatic metastases at diagnosis or who have not received any antineoplastic therapy for metastatic disease will be registered in the study and sent to a screening phase. Randomization will be proposed to patients with progressive hepatic or symptomatic disease.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

At registration

  • 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
  • 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

At randomization

  • Confirmed criteria as per registration
  • 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 tumour, that doesn't need of a symptomatic therapy with analogues of somatostatin [insulinoma, gastrinoma, ACTHoma], it is necessary to wait for radiological progression)

Exclusion Criteria:

At registration

  • Previous loco-regional postsurgical treatment
  • Low 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 instable 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

At randomization

  • Patients with progression of disease only on the extra-hepatic localizations during screening phase
  • Patients with progression disease on critical location such as: brain, spinal cord, lung with respiratory impairment, symptomatic vertebral lesions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755182

Contacts
Contact: Francesco Perrone, M.D., Ph.D. +39 081 5903571 francesco.perrone@usc-intnapoli.net
Contact: Marilina Piccirillo, M.D. +39 081 5903383 marilina.piccirillo@usc-intnapoli.net

Locations
Italy
Albano Laziale Ospedale "Regina Apoltolorum" Not yet recruiting
Albano Laziale, Italy
Università di Ferrara Not yet recruiting
Ferrara, Italy
Università di Genova Not yet recruiting
Genova, Italy
Istituto Nazionale Tumori Not yet recruiting
Milano, Italy
Istituto Europeo di Oncologia Not yet recruiting
Milano, Italy
Ospedale San Raffaele Not yet recruiting
MIlano, Italy
Istituto Nazionale dei Tumori Recruiting
Napoli, Italy
Istituto Regina Elena Not yet recruiting
Roma, Italy
Azienda Ospedaliero-Universitaria S.M. della Misericordia di Udine Not yet recruiting
Udine, Italy
Università di Verona Policlinico GB Rossi Not yet recruiting
Verona, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Federico II University
Second University of Naples
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 Second University of Naples
Principal Investigator: MC Piccirillo, MD NCI Naples
  More Information

No publications provided

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01755182     History of Changes
Other Study ID Numbers: LOTUS, 2011-006097-76
Study First Received: December 18, 2012
Last Updated: February 20, 2014
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Neuroendocrine Tumors
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Octreotide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014