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

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ClinicalTrials.gov Identifier: NCT01755182
Recruitment Status : Terminated (difficulty enrollment, no patients received treatment)
First Posted : December 24, 2012
Last Update Posted : May 6, 2016
Sponsor:
Collaborators:
Federico II University
University of Campania "Luigi Vanvitelli"
Information provided by (Responsible Party):
National Cancer Institute, Naples

Tracking Information
First Submitted Date  ICMJE December 18, 2012
First Posted Date  ICMJE December 24, 2012
Last Update Posted Date May 6, 2016
Study Start Date  ICMJE July 2013
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
progression free survival [ Time Frame: two years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01755182 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 18, 2012)
exploratory analysis of prognostic factors [ Time Frame: 3 years ]
clinical factors will be explored in relation to patient outcomes
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Systemic Therapy With or Without Upfront Transarterial Embolization for Inoperable Liver Metastasis of Neuroendocrine Tumors
Official Title  ICMJE 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.
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Pharmacologic therapy
    Patients in this arm receive systemic pharmacologic therapy alone
    Intervention: Drug: approved pharmacologic therapy
  • Experimental: TAE and pharmacologic therapy
    Patients in this arm receive systemic pharmacologic therapy and TAE
    Interventions:
    • Drug: approved pharmacologic therapy
    • Procedure: TAE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 5, 2016)
1
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2012)
140
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01755182
Other Study ID Numbers  ICMJE LOTUS
2011-006097-76 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute, Naples
Study Sponsor  ICMJE National Cancer Institute, Naples
Collaborators  ICMJE
  • Federico II University
  • University of Campania "Luigi Vanvitelli"
Investigators  ICMJE
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
PRS Account National Cancer Institute, Naples
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP