Systemic Therapy With or Without Upfront Transarterial Embolization for Inoperable Liver Metastasis of Neuroendocrine Tumors (LOTUS)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2014 by National Cancer Institute, Naples
Sponsor:
National Cancer Institute, Naples
Collaborators:
Federico II University
Second University of Naples
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT01755182
First received: December 18, 2012
Last updated: December 29, 2014
Last verified: December 2014
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroendocrine Tumors |
Drug: approved pharmacologic therapy Procedure: TAE |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute, Naples:
Primary Outcome Measures:
- progression free survival [ Time Frame: two years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- number of objective responses [ Time Frame: measured at 3 months and 6 months ] [ Designated as safety issue: No ]
- changes in quality of life [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
- worst grade adverse event per patient [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Other Outcome Measures:
- exploratory analysis of prognostic factors [ Time Frame: 3 years ] [ Designated as safety issue: No ]clinical factors will be explored in relation to patient outcomes
| Estimated Enrollment: | 140 |
| Study Start Date: | July 2013 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Pharmacologic therapy
Patients in this arm receive systemic pharmacologic therapy alone
|
Drug: approved pharmacologic therapy
Other Name: somatostatin analog or other medicine with proven efficacy
|
|
Experimental: TAE and pharmacologic therapy
Patients in this arm receive systemic pharmacologic therapy and TAE
|
Drug: approved pharmacologic therapy
Other Name: somatostatin analog or other medicine with proven efficacy
Procedure: TAE
after randomization, and after 3 months
Other Name: transarterial embolization
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755182
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755182
Contacts
| Contact: Francesco Perrone, M.D., Ph.D. | +39 081 5903571 | francesco.perrone@usc-intnapoli.net | |
| Contact: Marilina Piccirillo, M.D. | +39 081 5903383 | marilina.piccirillo@usc-intnapoli.net |
Locations
| Italy | |
| Albano Laziale Ospedale "Regina Apoltolorum" | Not yet recruiting |
| Albano Laziale, Italy | |
| Università di Ferrara | Not yet recruiting |
| Ferrara, Italy | |
| Università di Genova | Not yet recruiting |
| Genova, Italy | |
| Ospedale San Raffaele | Not yet recruiting |
| MIlano, Italy | |
| Istituto Nazionale Tumori | Not yet recruiting |
| Milano, Italy | |
| Istituto Europeo di Oncologia | Not yet recruiting |
| Milano, Italy | |
| Istituto Nazionale dei Tumori | Recruiting |
| Napoli, Italy | |
| Istituto Regina Elena | Not yet recruiting |
| Roma, Italy | |
| Azienda Ospedaliero-Universitaria S.M. della Misericordia di Udine | Not yet recruiting |
| Udine, Italy | |
| Università di Verona Policlinico GB Rossi | Recruiting |
| Verona, Italy | |
Sponsors and Collaborators
National Cancer Institute, Naples
Federico II University
Second University of Naples
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 | Second University of Naples | |
| Principal Investigator: | MC Piccirillo, MD | NCI Naples |
More Information
No publications provided
| Responsible Party: | National Cancer Institute, Naples |
| ClinicalTrials.gov Identifier: | NCT01755182 History of Changes |
| Other Study ID Numbers: | LOTUS, 2011-006097-76 |
| Study First Received: | December 18, 2012 |
| Last Updated: | December 29, 2014 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by National Cancer Institute, Naples:
|
locoregional treatment liver metastases transarterial embolization upfront treatment inoperable |
octreotide gastroenteropancreatic (GEP)primary pulmonary primary primary unknown origin systemic therapy |
Additional relevant MeSH terms:
|
Apudoma Carcinoid Tumor Neuroendocrine Tumors Adenocarcinoma Adenoma Carcinoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors |
ClinicalTrials.gov processed this record on February 27, 2015