Systemic Therapy With or Without Upfront Transarterial Embolization for Inoperable Liver Metastasis of Neuroendocrine Tumors (LOTUS)
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| ClinicalTrials.gov Identifier: NCT01755182 |
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Recruitment Status :
Terminated
(difficulty enrollment, no patients received treatment)
First Posted : December 24, 2012
Last Update Posted : May 6, 2016
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Sponsor:
National Cancer Institute, Naples
Collaborators:
Federico II University
University of Campania "Luigi Vanvitelli"
Information provided by (Responsible Party):
National Cancer Institute, Naples
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neuroendocrine Tumors | Drug: approved pharmacologic therapy Procedure: TAE | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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. |
| Study Start Date : | July 2013 |
| Actual Primary Completion Date : | March 2016 |
| Actual Study Completion Date : | March 2016 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Pharmacologic therapy
Patients in this arm receive systemic pharmacologic therapy alone
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Drug: approved pharmacologic therapy
Other Name: somatostatin analog or other medicine with proven efficacy |
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Experimental: TAE and pharmacologic therapy
Patients in this arm receive systemic pharmacologic therapy and TAE
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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 |
Primary Outcome Measures :
- progression free survival [ Time Frame: two years ]
Secondary Outcome Measures :
- overall survival [ Time Frame: 3 years ]
- number of objective responses [ Time Frame: measured at 3 months and 6 months ]
- changes in quality of life [ Time Frame: up to 6 months ]
- worst grade adverse event per patient [ Time Frame: 6 months ]
Other Outcome Measures:
- exploratory analysis of prognostic factors [ Time Frame: 3 years ]clinical factors will be explored in relation to patient outcomes
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755182
Locations
| Italy | |
| Albano Laziale Ospedale "Regina Apoltolorum" | |
| Albano Laziale, Italy | |
| Università di Ferrara | |
| Ferrara, Italy | |
| Università di Genova | |
| Genova, Italy | |
| Istituto Europeo di Oncologia | |
| Milano, Italy | |
| Istituto Nazionale Tumori | |
| Milano, Italy | |
| Ospedale San Raffaele | |
| MIlano, Italy | |
| Istituto Nazionale dei Tumori | |
| Napoli, Italy | |
| Ospedale Cardarelli | |
| Napoli, Italy | |
| Presidio Monaldi - AORN Ospedale dei Colli | |
| Napoli, Italy | |
| Istituto Regina Elena | |
| Roma, Italy | |
| Azienda Ospedaliero-Universitaria S.M. della Misericordia di Udine | |
| Udine, Italy | |
| Università di Verona Policlinico GB Rossi | |
| Verona, Italy | |
Sponsors and Collaborators
National Cancer Institute, Naples
Federico II University
University of Campania "Luigi Vanvitelli"
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 |
| Responsible Party: | National Cancer Institute, Naples |
| ClinicalTrials.gov Identifier: | NCT01755182 History of Changes |
| Other Study ID Numbers: |
LOTUS 2011-006097-76 ( EudraCT Number ) |
| First Posted: | December 24, 2012 Key Record Dates |
| Last Update Posted: | May 6, 2016 |
| Last Verified: | May 2016 |
Keywords provided by National Cancer Institute, Naples:
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locoregional treatment liver metastases transarterial embolization upfront treatment inoperable |
octreotide gastroenteropancreatic (GEP)primary pulmonary primary primary unknown origin systemic therapy |
Additional relevant MeSH terms:
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Neoplasm Metastasis Neuroendocrine Tumors Neoplastic Processes Neoplasms Pathologic Processes Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms, Nerve Tissue Somatostatin Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |