Systemic Therapy With or Without Upfront Transarterial Embolization for Inoperable Liver Metastasis of Neuroendocrine Tumors (LOTUS)
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ClinicalTrials.gov Identifier: NCT01755182 |
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
Tracking Information | ||||||||||||||||||||||
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First Submitted Date ICMJE | December 18, 2012 | |||||||||||||||||||||
First Posted Date ICMJE | December 24, 2012 | |||||||||||||||||||||
Last Update Posted Date | May 6, 2016 | |||||||||||||||||||||
Study Start Date ICMJE | July 2013 | |||||||||||||||||||||
Actual Primary Completion Date | March 2016 (Final data collection date for primary outcome measure) | |||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
progression free survival [ Time Frame: two years ] | |||||||||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | |||||||||||||||||||||
Change History | ||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||||||||||||||||||||
Current Other Pre-specified 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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Original Other Pre-specified Outcome Measures | Same as current | |||||||||||||||||||||
Descriptive Information | ||||||||||||||||||||||
Brief Title ICMJE | Systemic Therapy With or Without Upfront Transarterial Embolization for Inoperable Liver Metastasis of Neuroendocrine Tumors | |||||||||||||||||||||
Official Title ICMJE | 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. | |||||||||||||||||||||
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 | |||||||||||||||||||||
Detailed Description | Not Provided | |||||||||||||||||||||
Study Type ICMJE | Interventional | |||||||||||||||||||||
Study Phase ICMJE | Phase 3 | |||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Neuroendocrine Tumors | |||||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||||||||
Recruitment Status ICMJE | Terminated | |||||||||||||||||||||
Actual Enrollment ICMJE |
1 | |||||||||||||||||||||
Original Estimated Enrollment ICMJE |
140 | |||||||||||||||||||||
Actual Study Completion Date ICMJE | March 2016 | |||||||||||||||||||||
Actual Primary Completion Date | March 2016 (Final data collection date for primary outcome measure) | |||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | |||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||||||||
Listed Location Countries ICMJE | Italy | |||||||||||||||||||||
Removed Location Countries | ||||||||||||||||||||||
Administrative Information | ||||||||||||||||||||||
NCT Number ICMJE | NCT01755182 | |||||||||||||||||||||
Other Study ID Numbers ICMJE | LOTUS 2011-006097-76 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | |||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||||||||
Responsible Party | National Cancer Institute, Naples | |||||||||||||||||||||
Study Sponsor ICMJE | National Cancer Institute, Naples | |||||||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | National Cancer Institute, Naples | |||||||||||||||||||||
Verification Date | May 2016 | |||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |