- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01755182
Systemic Therapy With or Without Upfront Transarterial Embolization for Inoperable Liver Metastasis of Neuroendocrine Tumors (LOTUS)
May 5, 2016 updated by: National Cancer Institute, Naples
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.
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Albano Laziale, Italy
- Albano Laziale Ospedale "Regina Apoltolorum"
-
Ferrara, Italy
- Università di Ferrara
-
Genova, Italy
- Universita di Genova
-
MIlano, Italy
- Ospedale San Raffaele
-
Milano, Italy
- Istituto Europeo di Oncologia
-
Milano, Italy
- Istituto Nazionale Tumori
-
Napoli, Italy
- Istituto Nazionale dei Tumori
-
Napoli, Italy
- Ospedale Cardarelli
-
Napoli, Italy
- Presidio Monaldi - AORN Ospedale dei Colli
-
Roma, Italy
- Istituto Regina Elena
-
Udine, Italy
- Azienda Ospedaliero-Universitaria S.M. della Misericordia di Udine
-
Verona, Italy
- Università di Verona Policlinico GB Rossi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pharmacologic therapy
Patients in this arm receive systemic pharmacologic therapy alone
|
Other Names:
|
Experimental: TAE and pharmacologic therapy
Patients in this arm receive systemic pharmacologic therapy and TAE
|
Other Names:
after randomization, and after 3 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression free survival
Time Frame: two years
|
two years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 3 years
|
3 years
|
number of objective responses
Time Frame: measured at 3 months and 6 months
|
measured at 3 months and 6 months
|
changes in quality of life
Time Frame: up to 6 months
|
up to 6 months
|
worst grade adverse event per patient
Time Frame: 6 months
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
exploratory analysis of prognostic factors
Time Frame: 3 years
|
clinical factors will be explored in relation to patient outcomes
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: A Colao, M.D., Federico II University
- Principal Investigator: A Faggiano, M.D., Federico II University
- Principal Investigator: R D'Angelo, M.D., NCI Naples
- Principal Investigator: F Fiore, MD, NCI Naples
- Principal Investigator: F Perrone, MD, NCI Naples
- Principal Investigator: C Gallo, MD, University of Campania "Luigi Vanvitelli"
- Principal Investigator: MC Piccirillo, MD, NCI Naples
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
December 18, 2012
First Submitted That Met QC Criteria
December 18, 2012
First Posted (Estimate)
December 24, 2012
Study Record Updates
Last Update Posted (Estimate)
May 6, 2016
Last Update Submitted That Met QC Criteria
May 5, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neoplastic Processes
- Neoplasm Metastasis
- Neuroendocrine Tumors
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Somatostatin
Other Study ID Numbers
- LOTUS
- 2011-006097-76 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neuroendocrine Tumors
-
Jiangsu HengRui Medicine Co., Ltd.RecruitingAdvanced Gastroenteropancreatic Neuroendocrine TumorChina
-
Jiangsu HengRui Medicine Co., Ltd.Not yet recruitingAdvanced Gastroenteropancreatic Neuroendocrine Tumor
-
Grupo Espanol de Tumores NeuroendocrinosActive, not recruitingNeuroendocrine Tumors | Neuroendocrine Neoplasm | Gastroenteropancreatic Neuroendocrine TumorSpain
-
Australasian Gastro-Intestinal Trials GroupCompletedMidgut Neuroendocrine Tumours | Pancreatic Neuroendocrine TumoursAustralia
-
National Health Research Institutes, TaiwanNational Taiwan University Hospital; Mackay Memorial Hospital; China Medical... and other collaboratorsRecruitingNeuroendocrine Tumors,GastroenteropancreaticTaiwan
-
Amr Mohamed MDNovatek PharmaceuticalsRecruitingNeuroendocrine Carcinoma | Gastroenteropancreatic Neuroendocrine Tumor | Gastroenteropancreatic Neuroendocrine Neoplasm | Mixed Neuroendocrine-Non Neuroendocrine NeoplasmUnited States
-
TaiRx, Inc.Active, not recruitingNeuroendocrine Tumors | Gastro-enteropancreatic Neuroendocrine Tumor | Neuroendocrine Carcinoma | Pancreatic Neuroendocrine Tumor | Lung Neuroendocrine NeoplasmTaiwan
-
Francesco De CobelliCompleted
-
Memorial Sloan Kettering Cancer CenterRecruitingNeuroendocrine Tumors | Liver-Dominant Metastatic Pancreatic Neuroendocrine TumorsUnited States
-
Oslo University HospitalUniversity Hospital of North Norway; Haukeland University Hospital; St. Olavs...RecruitingPancreatic Neuroendocrine Tumors, WHO Grade I-IINorway
Clinical Trials on approved pharmacologic therapy
-
University Medicine GreifswaldCompleted
-
Translational Drug DevelopmentSide-Out FoundationCompletedMetastatic Breast CancerUnited States
-
Boston Scientific CorporationRecruiting
-
Boston Scientific CorporationCompleted
-
University of HawaiiCompletedPain Management | Pregnancy TerminationUnited States
-
Springfield CollegeNational Heart, Lung, and Blood Institute (NHLBI)CompletedHypertension | Diabetes | Chronic Kidney DiseaseUnited States
-
Omega OphthalmicsCompleted
-
University of California, San FranciscoCompletedEarly Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus (PDA:TOLERATE)Necrotizing Enterocolitis | Surgery | Patent Ductus Arteriosus | Intestinal PerforationUnited States, Turkey, Sweden, United Kingdom
-
Richard Ronan MurphyCompletedDementia Alzheimers | Disruptive BehaviorUnited States
-
University of Erlangen-Nürnberg Medical SchoolRecruitingRenal Cell Carcinoma | Esophageal Cancer | NSCLC | Urothelial Carcinoma | HNSCC | Squamous Cell Carcinoma of the Skin | Small Cell Bronchial CarcinomasGermany