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

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Trial Identification

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

Official Title: A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor-Positive (SSTR+), Neuroendocrine Tumours of GastroEnteric or Pancreatic Origin

Study ID: NCT04919226

Study Description

Brief Summary: The purpose of the study is to evaluate the efficacy, safety \& patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Stanford Cancer Center, Palo Alto, California, United States

University of Colorado Hospital, Nuclear Medicine, Aurora, Colorado, United States

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Mayo Clinic - Rochester, Department of Oncology, Rochester, Minnesota, United States

Washington University Alvin J. Siteman Cancer Center, Saint Louis, Missouri, United States

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

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

Duke University School of Medicine, Duke Cancer Institute, Durham, North Carolina, United States

Oregon Health and Science University, Portland, Oregon, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Texas Oncology, Dallas, Texas, United States

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

University of Utah, Huntsman Cancer Institute, Salt Lake City, Utah, United States

Royal North Shore Hospital, St. Leonards, New South Wales, Australia

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

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

Nantes University Hospital Center - Hotel Dieu Hospital, Nantes, Cedex, France

Edouard Herriot Hospital, Medical Oncology Unit, Lyon, , France

IUCT Oncopole - Institut Universitaire du Cancer de Toulouse, Toulouse, , France

Charite - University Hospital Berlin, Berlin, , Germany

University Hospital Bonn, Department of Nuclear Medicine, Bonn, , Germany

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

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

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

HCG Cancer Centre, Medical Oncology, Bangalore, Karnataka, India

Tata Memorial Hospital, Nuclear Medicine & Molecular Imaging, Mumbai, , India

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

European Institute of Oncology (IEO), IRCCS, Milan, , Italy

University Hospital "Federico II", Department of Molecular and Clinical Endocrinology and Oncology, Naples, , Italy

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

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

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

ICO Hospitalet, Catalan Institute of Oncology, Barcelona, , Spain

University General Hospital Gregorio Maranon, Madrid, , Spain

University Hospital 12 de Octubre, Department of Gastroenterology, Madrid, , Spain

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

University Hospital Complex of Santiago (CHUS), Santiago De Compostela, , Spain

University and Polytechnic Hospital La Fe, Endocrinology, Valencia, , Spain

Uppsala University Hospital, Department of Oncology, Uppsala, , Sweden

Royal Free Hospital, London, , United Kingdom

King's College Hospital, London, , United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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