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

National Cancer Institute, Naples

Status and phase: Terminated; Phase 3

Conditions: Neuroendocrine Tumors

Treatments: Drug: approved pharmacologic therapy; Procedure: TAE

Study type: Interventional

Funder types: Other

Identifiers

NCT01755182

2011-006097-76 (EudraCT Number)

LOTUS

Details and patient eligibility

About

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

Enrollment: 1 patient

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Pharmacologic therapy

Active Comparator group

Description:

Patients in this arm receive systemic pharmacologic therapy alone

Treatment:

Drug: approved pharmacologic therapy

TAE and pharmacologic therapy

Experimental group

Description:

Patients in this arm receive systemic pharmacologic therapy and TAE

Treatment:

Procedure: TAE

Drug: approved pharmacologic therapy