Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

259

Participants

Timeline

Start Date

December 21, 2021

Primary Completion Date

June 30, 2027

Study Completion Date

September 30, 2027

Conditions
Neuroendocrine Tumors
Interventions
DRUG

177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT

Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-edotreotide with a defined number of cycles will be administered.

DRUG

CAPTEM (Capecitabine and Temozolomide)

Best standard of care treatment (investigator's choice \[from the protocol comparator list\]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.

OTHER

Amino-Acid Solution

The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.

DRUG

Everolimus

Best standard of care treatment (investigator's choice \[from the protocol comparator list\]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.

DRUG

FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)

Best standard of care treatment (investigator's choice \[from the protocol comparator list\]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.

Trial Locations (42)

2065

Royal North Shore Hospital, St Leonards

10065

Memorial Sloan-Kettering Cancer Center, New York

10128

ICAHN School of Medicine at Mount Sinai, Tish Cancer Institute, New York

13353

Charite - University Hospital Berlin, Berlin

15706

University Hospital Complex of Santiago (CHUS), Santiago de Compostela

20141

European Institute of Oncology (IEO), IRCCS, Milan

27710

Duke University School of Medicine, Duke Cancer Institute, Durham

28007

University General Hospital Gregorio Maranon, Madrid

28041

University Hospital 12 de Octubre, Department of Gastroenterology, Madrid

31059

IUCT Oncopole - Institut Universitaire du Cancer de Toulouse, Toulouse

33011

Central University Hospital de Asturias (HUCA), IUOPA - Universitary Institute of Oncology, Oviedo

33604

Haut-Leveque Hospital, Department of Hepatogastroenterology and Digestive Tract Oncology, Pessac

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

44093

Nantes University Hospital Center - Hotel Dieu Hospital, Nantes

45147

University Duisburg-Essen, University Hospital Essen, Clinic for Nuclear Medicine, Essen

46026

University and Polytechnic Hospital La Fe, Endocrinology, Valencia

53127

University Hospital Bonn, Department of Nuclear Medicine, Bonn

55905

Mayo Clinic - Rochester, Department of Oncology, Rochester

63110

Washington University Alvin J. Siteman Cancer Center, St Louis

69003

Edouard Herriot Hospital, Medical Oncology Unit, Lyon

75246

Texas Oncology, Dallas

77030

University of Texas MD Anderson Cancer Center, Houston

80045

University of Colorado Hospital, Nuclear Medicine, Aurora

84112

University of Utah, Huntsman Cancer Institute, Salt Lake City

91054

University Hospital Erlangen, Department of Internal Medicine I - Endocrinology, Erlangen

94305

Stanford Cancer Center, Palo Alto

98125

"University Polyclinic Hospital G. Martino, Department of Biomedical Sciences, Dentistry and Morphological and Functional Imaging, Complex Operational Unit of Nuclear Medicine", Messina

110029

All India Institute Of Medical Sciences, Nuclear Medicine, New Delhi

200000

Fudan University Shanghai Cancer Center, Shanghai

214122

Affiliated Hospital of Jiangnan University, Wuxi

400012

Tata Memorial Hospital, Nuclear Medicine & Molecular Imaging, Mumbai

560027

HCG Cancer Centre, Medical Oncology, Bangalore

02215

Dana Farber Cancer Institute, Boston

97239-3098

Oregon Health and Science University, Portland

19111-2497

Fox Chase Cancer Center, Philadelphia

VIC 3000

Peter MacCallum Cancer Centre, Melbourne

00168

"University Polyclinic Foundation Agostino Gemelli - IRCCS, Complex Operative Unit of Medical Oncology", Rome

1081-HV

VU Medical Center (VUMC), Department of Medical Oncology, Amsterdam

3015 GD

Erasmus University Medical Center Rotterdam, Rotterdam

08035

University Hospital Vall d'Hebron, Department of Medical Oncology, Barcelona

199-203

ICO Hospitalet, Catalan Institute of Oncology, Barcelona

SE5 9RS

King's College Hospital, London

All Listed Sponsors
lead

ITM Solucin GmbH

INDUSTRY