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

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Neuroendocrine Tumors

Intervention / Treatment
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* Drug: approved pharmacologic therapy
* Procedure: TAE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pharmacologic therapy<br>Patients in this arm receive systemic pharmacologic therapy alone | Drug: approved pharmacologic therapy<br> <br> * Other names: somatostatin analog or other medicine with proven efficacy;|
| Experimental: TAE and pharmacologic therapy<br>Patients in this arm receive systemic pharmacologic therapy and TAE | Drug: approved pharmacologic therapy<br> <br> * Other names: somatostatin analog or other medicine with proven efficacy;Procedure: TAE<br>* after randomization, and after 3 months<br>* Other names: transarterial embolization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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locoregional treatment, liver metastases, transarterial embolization, upfront treatment, inoperable, octreotide, gastroenteropancreatic (GEP)primary, pulmonary primary, primary unknown origin, systemic therapy