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

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.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01755182

Acronym

LOTUS

Enrollment

Registered

2012-12-24

Start date

2013-07-31

Completion date

2016-03-31

Last updated

2016-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Tumors

Keywords

locoregional treatment, liver metastases, transarterial embolization, upfront treatment, inoperable, octreotide, gastroenteropancreatic (GEP)primary, pulmonary primary, primary unknown origin, systemic therapy

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

Interventions

DRUGapproved pharmacologic therapy

PROCEDURETAE

after randomization, and after 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
progression free survival	two years

Secondary

Measure	Time frame
overall survival	3 years
number of objective responses	measured at 3 months and 6 months
changes in quality of life	up to 6 months
worst grade adverse event per patient	6 months

Other

Measure	Time frame	Description
exploratory analysis of prognostic factors	3 years	clinical factors will be explored in relation to patient outcomes

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026