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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
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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