Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients
NCT ID: NCT03049189
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
309 participants
INTERVENTIONAL
2017-02-02
2029-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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177Lu-edotreotide PRRT
177Lu-edotreotide (177Lu-DOTATOC)
A maximum of four cycles of 7.5 ± 0.7 GBq (gigabequerel) 177Lu-edotreotide, each.
Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, 90 days apart (total duration: 270 days/9 months)
177Lu-edotreotide PRRT
PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.
Amino-Acid Solution
The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of 25 g lysine and 25 g arginine diluted in 2000 mL of electrolyte solution, infused over 4 - 6 h, starting 30 - 60 min before PRRT
Everolimus
Everolimus (Afinitor ®)
Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS)
Everolimus
Everolimus will be administered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.
Interventions
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177Lu-edotreotide PRRT
PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.
Everolimus
Everolimus will be administered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.
Amino-Acid Solution
The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of 25 g lysine and 25 g arginine diluted in 2000 mL of electrolyte solution, infused over 4 - 6 h, starting 30 - 60 min before PRRT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease per RECIST 1.1
* Somatostatin receptor positive (SSTR+) disease
* Progressive disease based on RECIST 1.1. criteria as evidenced by two morphological imaging examinations made with the same imaging method (either CT or MRI)
Exclusion Criteria
* Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or everolimus or any other Rapamycin derivative
* Prior exposure to any peptide receptor radionuclide therapy (PRRT)
* Prior therapy with mTor inhibitors
* Prior EFR (external field radiation) to GEP-NET lesions within 90 days before randomisation or radioembolisation therapy
* Therapy with an investigational compound and/or medical device within 30 days prior to randomisation
* Indication for surgical lesion removal with curative potential
* Planned alternative therapy (for the period of study participation)
* Serious non-malignant disease
* Clinically relevant renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially interfering with the safety of the study treatments
* Pregnant or breast-feeding women
* Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders) or any other vulnerable population to that sense (e.g. persons institutionalised, incarcerated etc.).
18 Years
ALL
No
Sponsors
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ABX CRO
OTHER
PSI CRO
INDUSTRY
ITM Solucin GmbH
INDUSTRY
Responsible Party
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Locations
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Banner Health d.b.a. Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Stanford University
Stanford, California, United States
Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Excel Diagnostics & Nuclear Oncology Center
Houston, Texas, United States
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Olivia Newton-John Cancer & Wellness Centre, Austin Hospital
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Allgemeines Krankenhaus Wien
Vienna, , Austria
Institut Jules Bordet
Brussels, , Belgium
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
University Hospital Olomouc
Olomouc, , Czechia
University Hospital Motol
Prague, , Czechia
Hospices civils de Lyon
Bron, , France
Centre Jean Perrin
Clermont-Ferrand, , France
HP Hôpital Beaujon
Clichy, , France
Institut de Recherche en Cancérologie de Montpellier (IRCM)
Montpellier, , France
CHU de Nantes - Hôtel Dieu
Nantes, , France
IUCT-Oncopole
Toulouse, , France
Zentralklinik Bad Berka GmbH
Bad Berka, , Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Universitätsklinikum Essen
Essen, , Germany
University Medical Center, Abteilung für Nuklearmedizin
Hamburg, , Germany
Universitätsklinikum Magdeburg A.ö.R., Otto-von-Guericke Universität
Magdeburg, , Germany
Philipps Universität Marburg
Marburg, , Germany
Klinikum rechts der Isar Technische Universität München
Munich, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Universitätsklinikum Würzburg
Würzburg, , Germany
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl
Meldola, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
European Institute of Oncology (EIO)
Milan, , Italy
Academic Medical Center, University of Amsterdam
Amsterdam, , Netherlands
MSC Memorial Cancer Centre
Gliwice, , Poland
"Gammed" Izabela Chuchrowksa
Warsaw, , Poland
University Cape Town (UCT), Groote Schuur Hospital
Cape Town, , South Africa
University of Pretoria & Steve Biko Academic Hospital
Pretoria, , South Africa
Vall d'Hebron University Hospital
Barcelona, , Spain
ICO Hospitalet, Granvia de l'Hospitalet
Barcelona, , Spain
MD Anderson Cancer Center Madrid
Madrid, , Spain
University Hospital 12 de Octubre
Madrid, , Spain
Central University Hospital de Asturias (HUCA)
Oviedo, , Spain
University and Polytechnic Hospital La Fe
Valencia, , Spain
Universitätsspital Basel
Basel, , Switzerland
Inselspital, Universitätsspital Bern
Bern, , Switzerland
UniversitätsSpital Zürich
Zurich, , Switzerland
Royal Free NHS Foundation Trust
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Other Identifiers
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ITM-LET-01
Identifier Type: -
Identifier Source: org_study_id
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