Neuroendocrine TumorsPhase 3LOTUSNCT01755182
Systemic Therapy With or Without Upfront Transarterial Embolization for Inoperable Liver Metastasis of Neuroendocrine Tumors
A Phase 3 study testing approved pharmacologic therapy and TAE in people with Neuroendocrine Tumors, run by National Cancer Institute, Naples at 12 sites in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- approved pharmacologic therapy and TAE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 12 sitesItaly
- Study dates
- Jul 2013to Mar 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites
Albano Laziale Ospedale "Regina Apoltolorum"
Albano Laziale
Università di Ferrara
Ferrara
Università di Genova
Genova
Istituto Europeo di Oncologia
Milan
Istituto Nazionale Tumori
Milan
Ospedale San Raffaele
Milan
Istituto Nazionale dei Tumori
Naples
Ospedale Cardarelli
Naples
Presidio Monaldi - AORN Ospedale dei Colli
Naples
Istituto Regina Elena
Roma
Azienda Ospedaliero-Universitaria S.M. della Misericordia di Udine
Udine
Università di Verona Policlinico GB Rossi
Verona
About this study
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.
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
- Conditions
- Neuroendocrine Tumors
- Being tested
- approved pharmacologic therapy, TAE
- Keywords
- locoregional treatment, liver metastases, transarterial embolization, upfront treatment, inoperable, octreotide, gastroenteropancreatic (GEP)primary, pulmonary primary, primary unknown origin, systemic therapy
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
approved pharmacologic therapyDrug
Also called somatostatin analog or other medicine with proven efficacy
TAEProcedure or surgery
Also called transarterial embolization
after randomization, and after 3 months
| Study group | Role | What they receive |
|---|---|---|
| Pharmacologic therapy | Active comparator | Patients in this arm receive systemic pharmacologic therapy alone Receives: Drug: approved pharmacologic therapy |
| TAE and pharmacologic therapy | Experimental | Patients in this arm receive systemic pharmacologic therapy and TAE Receives: Drug: approved pharmacologic therapy; Procedure: TAE |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: two years
Secondary outcomes (4)
overall survival
Measured: 3 years
number of objective responses
Measured: measured at 3 months and 6 months
changes in quality of life
Measured: up to 6 months
worst grade adverse event per patient
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startJul 2013
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: difficulty enrollment, no patients received treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University, University of Campania Luigi Vanvitelli
- Responsible party
- Sponsor
- Investigators
- A Colao, M.D., Principal investigator, Federico II UniversityA Faggiano, M.D., Principal investigator, Federico II UniversityR D'Angelo, M.D., Principal investigator, NCI NaplesF Fiore, MD, Principal investigator, NCI NaplesF Perrone, MD, Principal investigator, NCI NaplesC Gallo, MD, Principal investigator, University of Campania Luigi VanvitelliMC Piccirillo, MD, Principal investigator, NCI Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755182
- Sponsor's protocol ID
- LOTUS
- Other IDs
- 2011-006097-76
- Acronym
- LOTUS
- Status last verified
- May 2016
- First submitted
- 18 Dec 2012
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01755182
- Acronym / sponsor ID
- LOTUS / LOTUS
- Conditions
- Neuroendocrine Tumors
- Keywords
- locoregional treatment, liver metastases, transarterial embolization, upfront treatment, inoperable, octreotide, gastroenteropancreatic (GEP)primary, pulmonary primary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty enrollment, no patients received treatment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Collaborators
- Federico II University, University of Campania Luigi Vanvitelli
- Study start
- Jul 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacologic therapy | Active comparator | Drug: approved pharmacologic therapyPatients in this arm receive systemic pharmacologic therapy alone |
| TAE and pharmacologic therapy | Experimental | Drug: approved pharmacologic therapy, Procedure: TAEPatients in this arm receive systemic pharmacologic therapy and TAE |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| approved pharmacologic therapyAlso: somatostatin analog or other medicine with proven efficacy | Drug | Pharmacologic therapy, TAE and pharmacologic therapy |
| TAEAlso: transarterial embolizationafter randomization, and after 3 months | Procedure or surgery | TAE and pharmacologic therapy |
Primary outcome
progression free survival
Time frame: two years
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: difficulty enrollment, no patients received treatment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A Colao, M.D. principal investigator
Federico II University
A Faggiano, M.D. principal investigator
Federico II University
R D'Angelo, M.D. principal investigator
NCI Naples
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing approved pharmacologic therapy and TAE in people with Neuroendocrine Tumors, run by National Cancer Institute, Naples at 12 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: difficulty enrollment, no patients received treatment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2016.