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

Primary Purpose

Neuroendocrine Tumors

Status

Terminated

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

approved pharmacologic therapy

TAE

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring locoregional treatment, liver metastases, transarterial embolization, upfront treatment, inoperable, octreotide, gastroenteropancreatic (GEP)primary, pulmonary primary, primary unknown origin, systemic therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Albano Laziale Ospedale "Regina Apoltolorum"
Università di Ferrara
Università di Genova
Istituto Europeo di Oncologia
Istituto Nazionale Tumori
Ospedale San Raffaele
Istituto Nazionale dei Tumori
Ospedale Cardarelli
Presidio Monaldi - AORN Ospedale dei Colli
Istituto Regina Elena
Azienda Ospedaliero-Universitaria S.M. della Misericordia di Udine
Università di Verona Policlinico GB Rossi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pharmacologic therapy

TAE and pharmacologic therapy

Arm Description

Patients in this arm receive systemic pharmacologic therapy alone

Patients in this arm receive systemic pharmacologic therapy and TAE

Outcomes

Primary Outcome Measures

progression free survival

Secondary Outcome Measures

overall survival

number of objective responses

changes in quality of life

worst grade adverse event per patient

Full Information

NCT ID

NCT01755182

First Posted

December 18, 2012

Last Updated

May 5, 2016

Sponsor

National Cancer Institute, Naples

Collaborators

Federico II University, University of Campania "Luigi Vanvitelli"

1. Study Identification

Unique Protocol Identification Number

NCT01755182

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Terminated

Why Stopped

difficulty enrollment, no patients received treatment

Study Start Date

July 2013 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute, Naples

Collaborators

Federico II University, University of Campania "Luigi Vanvitelli"

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroendocrine Tumors

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pharmacologic therapy

Arm Type

Active Comparator

Arm Description

Patients in this arm receive systemic pharmacologic therapy alone

Arm Title

TAE and pharmacologic therapy

Arm Type

Experimental

Arm Description

Patients in this arm receive systemic pharmacologic therapy and TAE

Intervention Type

Drug

Intervention Name(s)

approved pharmacologic therapy

Other Intervention Name(s)

somatostatin analog or other medicine with proven efficacy

Intervention Type

Procedure

Intervention Name(s)

TAE

Other Intervention Name(s)

transarterial embolization

Intervention Description

after randomization, and after 3 months

Primary Outcome Measure Information:

Title

progression free survival

Time Frame

two years

Secondary Outcome Measure Information:

Title

overall survival

Time Frame

3 years

Title

number of objective responses

Time Frame

measured at 3 months and 6 months

Title

changes in quality of life

Time Frame

up to 6 months

Title

worst grade adverse event per patient

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

exploratory analysis of prognostic factors

Description

clinical factors will be explored in relation to patient outcomes

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials: