Spots Global Cancer Trial Database for Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
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Trial Identification
Brief Title: Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
Official Title: A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
Study ID: NCT03972488
Study Description
Brief Summary: The aim of NETTER-2 is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients are eligible, as well as patients previously treated with SSAs in the absence of progression.
Detailed Description:
Keywords
Eligibility
Minimum Age: 15 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Yale Cancer Center, New Haven, Connecticut, United States
USF - H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
University of Iowa Hospitals and Clinics - Oncology, Iowa City, Iowa, United States
University of Kentucky UK Markey Cancer Center, Lexington, Kentucky, United States
Mayo Clinic - Oncology, Rochester, Minnesota, United States
MD Anderson Cancer Center, Houston, Texas, United States
London Health Sciences Centre, University of Western Ontario - Oncology, London, , Canada
Centre Hospitalier Universitaire de Quebec, Quebec, , Canada
Sunnybrook Health Sciences Centre, Toronto, , Canada
BC Cancer Agency, Vancouver, , Canada
CHU Paris Nord-Val de Seine, Clichy, , France
Hospices Civils de Lyon (HCL) - Hopital Edouard Herriot, Lyon, , France
Institut du Cancer de Montpellier - Oncology, Montpellier, , France
CHU-Hôtel Dieu Service de Médecine Nucléaire, Nantes, , France
Institut Gustave Roussy, Villejuif, , France
Universitätsklinikum Erlangen, Erlangen, , Germany
Universitätsklinikum Essen - Klinik für Nuklearmedizin, Essen, , Germany
A.O.di Bologna Policl.S.Orsola, Bologna, , Italy
University of Genova - Oncology, Genova, , Italy
Istituto Oncologico Romagnolo, Meldola, , Italy
Fondazione Irccs Istituto Nazionale Tumori, Milano, , Italy
Ieo, Irccs, Milano, , Italy
IRCCS fondazione Pascale - Oncology, Napoli, , Italy
Arcispedale Santa Maria Nuova, Reggio Emilia - Oncology, Reggio Emilia, , Italy
Azienda Ospedaliera Sant'Andrea - Università La Sapienza U.O.C. Mal App. Digerente e - Oncology, Roma, , Italy
Seoul National University Bundang Hospital, Seongnam-Si, , Korea, Republic of
Asan Medical Center - Oncology, Seoul, , Korea, Republic of
Seoul National University Hospital - Department of Internal Medicine, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System - Medical Oncology, Seoul, , Korea, Republic of
Erasmus Medisch Centrum, Rotterdam, , Netherlands
UMC Utrecht - Oncology, Utrecht, , Netherlands
Hospital Universitario Vall d'Hebrón, Barcelona, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
Guys And St Thomas Hospital, London, , United Kingdom
Kings College Hospital - Oncology, London, , United Kingdom
Royal Free Hospital, London, London, , United Kingdom
Weston Park Hospital, Sheffield, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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