Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

309

Participants

Timeline

Start Date

February 2, 2017

Primary Completion Date

November 27, 2024

Study Completion Date

November 30, 2029

Conditions
Neuroendocrine Tumors
Interventions
DRUG

177Lu-edotreotide PRRT

PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.

DRUG

Everolimus

Everolimus will be administered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.

OTHER

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

Trial Locations (52)

1000

Institut Jules Bordet, Brussels

1090

Allgemeines Krankenhaus Wien, Vienna

2065

Royal North Shore Hospital, Saint Leonards

3000

Peter MacCallum Cancer Centre, Melbourne

Universitaire Ziekenhuizen Leuven, Leuven

3010

Inselspital, Universitätsspital Bern, Bern

3084

Olivia Newton-John Cancer & Wellness Centre, Austin Hospital, Heidelberg

4031

Universitätsspital Basel, Basel

6150

Fiona Stanley Hospital, Murdoch

7925

University Cape Town (UCT), Groote Schuur Hospital, Cape Town

8091

UniversitätsSpital Zürich, Zurich

10117

Charité - Universitätsmedizin Berlin, Berlin

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20141

European Institute of Oncology (EIO), Milan

20251

University Medical Center, Abteilung für Nuklearmedizin, Hamburg

28033

MD Anderson Cancer Center Madrid, Madrid

28041

University Hospital 12 de Octubre, Madrid

31059

IUCT-Oncopole, Toulouse

33011

Central University Hospital de Asturias (HUCA), Oviedo

33612

Moffitt Cancer Center & Research Institute, Tampa

34298

Institut de Recherche en Cancérologie de Montpellier (IRCM), Montpellier

35043

Philipps Universität Marburg, Marburg

39120

Universitätsklinikum Magdeburg A.ö.R., Otto-von-Guericke Universität, Magdeburg

44093

CHU de Nantes - Hôtel Dieu, Nantes

45147

Universitätsklinikum Essen, Essen

46026

University and Polytechnic Hospital La Fe, Valencia

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl, Meldola

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

53127

Universitätsklinikum Bonn, Bonn

60611

Northwestern Memorial Hospital, Chicago

63011

Centre Jean Perrin, Clermont-Ferrand

69677

Hospices civils de Lyon, Bron

77042

Excel Diagnostics & Nuclear Oncology Center, Houston

81675

Klinikum rechts der Isar Technische Universität München, Munich

85234

Banner Health d.b.a. Banner MD Anderson Cancer Center, Gilbert

89081

Universitätsklinikum Ulm, Ulm

91054

Universitätsklinikum Erlangen, Erlangen

92110

HP Hôpital Beaujon, Clichy

94305

Stanford University, Stanford

97080

Universitätsklinikum Würzburg, Würzburg

99437

Zentralklinik Bad Berka GmbH, Bad Berka

775 20

University Hospital Olomouc, Olomouc

150 06

University Hospital Motol, Prague

1100DD

Academic Medical Center, University of Amsterdam, Amsterdam

44-100

MSC Memorial Cancer Centre, Gliwice

02-351

"Gammed Izabela Chuchrowksa", Warsaw

0001

University of Pretoria & Steve Biko Academic Hospital, Pretoria

08035

Vall d'Hebron University Hospital, Barcelona

08909

ICO Hospitalet, Granvia de l'Hospitalet, Barcelona

NW3 2QG

Royal Free NHS Foundation Trust, London

SE5 9RS

Kings College Hospital, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

ABX CRO

OTHER

collaborator

PSI CRO

INDUSTRY

lead

ITM Solucin GmbH

INDUSTRY