Clinical trial NCT01755182: Systemic Therapy With or Without Upfront Transarterial Embolization for Inoperable Liver Metastasis of Neuroendocrine Tumors
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Neuroendocrine Tumors
Keywords: locoregional treatment
liver metastases
transarterial embolization
upfront treatment
inoperable
octreotide
gastroenteropancreatic (GEP)primary
pulmonary primary
primary unknown origin
systemic therapy
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
Collaborators: name: Federico II University
name: University of Campania Luigi Vanvitelli
First posted: 2012-12-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: progression free survival
timeFrame: two years
Secondary outcomes:
measure: overall survival
timeFrame: 3 years
measure: number of objective responses
timeFrame: measured at 3 months and 6 months
measure: changes in quality of life
timeFrame: up to 6 months
measure: worst grade adverse event per patient
timeFrame: 6 months
Other outcomes:
measure: exploratory analysis of prognostic factors
timeFrame: 3 years
Locations:
city: Albano Laziale
country: Italy
facility: Albano Laziale Ospedale "Regina Apoltolorum"
city: Ferrara
country: Italy
facility: Università di Ferrara
city: Genova
country: Italy
facility: Università di Genova
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Milano
country: Italy
facility: Istituto Nazionale Tumori
city: MIlano
country: Italy
facility: Ospedale San Raffaele
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori
city: Napoli
country: Italy
facility: Ospedale Cardarelli
city: Napoli
country: Italy
facility: Presidio Monaldi - AORN Ospedale dei Colli
city: Roma
country: Italy
facility: Istituto Regina Elena
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria S.M. della Misericordia di Udine
city: Verona
country: Italy
facility: Università di Verona Policlinico GB Rossi
Study officials:
affiliation: Federico II University
name: A Colao, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Federico II University
name: A Faggiano, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NCI Naples
name: R D'Angelo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NCI Naples
name: F Fiore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NCI Naples
name: F Perrone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campania Luigi Vanvitelli
name: C Gallo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NCI Naples
name: MC Piccirillo, MD
role: PRINCIPAL_INVESTIGATOR
References: