Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study summary
The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) — From date of randomization until the date of first documented progression or death, assessed up to 30 months,
PFS determined as time elapsed between randomization, and the date of first objective report of tumor progression (evaluated by RECIST criteria v1.1) as evaluated by the Blinded Independent Central Review (BICR), or death.
Trial sites (52)
| Facility | City | Region | Status |
|---|---|---|---|
| Banner Health d.b.a. Banner MD Anderson Cancer Center | Gilbert | Arizona | |
| Stanford University | Stanford | California | |
| Moffitt Cancer Center & Research Institute | Tampa | Florida | |
| Northwestern Memorial Hospital | Chicago | Illinois | |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | |
| Excel Diagnostics & Nuclear Oncology Center | Houston | Texas | |
| Royal North Shore Hospital | Saint Leonards | New South Wales | |
| Olivia Newton-John Cancer & Wellness Centre, Austin Hospital | Heidelberg | Victoria | |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | |
| Fiona Stanley Hospital | Murdoch | Western 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 |
+ 12 more sites — see the full list on the official registry below.
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03049189 on ClinicalTrials.gov ↗ ← All trials in Belgium