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

Neuroendocrine Tumors Clinical Trial

— LOTUS  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01755182
• Other study ID #: LOTUS
• Secondary ID: 2011-006097-76
• Status: Terminated
• Phase: Phase 3
• First received: December 18, 2012
• Last updated: May 5, 2016
• Start date: July 2013
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Tumor
• Neuroendocrine Tumors

Intervention

Drug:
• approved pharmacologic therapy

Procedure:
• TAE
after randomization, and after 3 months

Locations

Country	Name	City	State
Italy	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

Sponsors (3)

Lead Sponsor	Collaborator
National Cancer Institute, Naples	Federico II University, Second University of Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	exploratory analysis of prognostic factors	clinical factors will be explored in relation to patient outcomes	3 years	No
Primary	progression free survival		two years	No
Secondary	overall survival		3 years	No
Secondary	number of objective responses		measured at 3 months and 6 months	No
Secondary	changes in quality of life		up to 6 months	No
Secondary	worst grade adverse event per patient		6 months	Yes