226
Participants
Start Date
January 8, 2020
Primary Completion Date
July 20, 2023
Study Completion Date
October 29, 2027
Lutathera
Lutathera is a sterile radiopharmaceutical supplied as a ready-to-use solution for infusion containing 177Lu-DOTA0-Tyr3-octreotate as a drug substance with a volumetric activity of 370 MBq/mL at reference date and time (calibration time). Each Lutathera infusion continued for 30 min.
30 mg Octreotide long acting repeatable (LAR) (Sandostatin LAR Depot)
"Sandostatin® LAR Depot (octreotide LAR) is a pharmaceutical that was available in single-use kits containing a 6-mL vial of 10 mg, 20 mg, or 30 mg strength for intramuscular injection, a syringe containing 2.5 mL of diluent, two sterile 1½ 19-gauge needles, and two alcohol wipes."
2.5% Lys-Arg sterile amino acid solution
Participants who received Lutathera were administered a concomitant 2.5% Lys-Arg solution for kidney protection, with each Lutathera dose. The 2.5% Lys-Arg solution was administered intravenously for 4 hours (infusion rate: 250 ml/h); the infusion was to start 30 minutes prior to the start of the Lutathera infusion and continue during (30 min) and up to at least 3 hours after the Lutathera infusion.
High dose 60 mg octreotide long-acting repeatable
"Sandostatin® LAR Depot (octreotide LAR) is a pharmaceutical that was available in single-use kits containing a 6-mL vial of 10 mg, 20 mg, or 30 mg strength for intramuscular injection, a syringe containing 2.5 mL of diluent, two sterile 1½ 19-gauge needles, and two alcohol wipes."
USF - H. Lee Moffitt Cancer Center and Research Institute, Tampa
University of Kentucky UK Markey Cancer Center, Lexington
University of Iowa Hospitals and Clinics - Oncology, Iowa City
Mayo Clinic - Oncology, Rochester
MD Anderson Cancer Center, Houston
Yale Cancer Center, New Haven
London Health Sciences Centre, University of Western Ontario - Oncology, London
Centre Hospitalier Universitaire de Quebec, Québec
Sunnybrook Health Sciences Centre, Toronto
BC Cancer Agency, Vancouver
CHU Paris Nord-Val de Seine, Clichy
Hospices Civils de Lyon (HCL) - Hopital Edouard Herriot, Lyon
Institut du Cancer de Montpellier - Oncology, Montpellier
CHU-Hôtel Dieu Service de Médecine Nucléaire, Nantes
Institut Gustave Roussy, Villejuif
Universitätsklinikum Erlangen, Erlangen
Universitätsklinikum Essen - Klinik für Nuklearmedizin, Essen
A.O.di Bologna Policl.S.Orsola, Bologna
University of Genova - Oncology, Genova
Istituto Oncologico Romagnolo, Meldola
Fondazione Irccs Istituto Nazionale Tumori, Milan
Ieo, Irccs, Milan
IRCCS fondazione Pascale - Oncology, Napoli
Arcispedale Santa Maria Nuova, Reggio Emilia - Oncology, Reggio Emilia
Azienda Ospedaliera Sant'Andrea - Università La Sapienza U.O.C. Mal App. Digerente e - Oncology, Roma
Erasmus Medisch Centrum, Rotterdam
UMC Utrecht - Oncology, Utrecht
Seoul National University Bundang Hospital, Seongnam-si
Asan Medical Center - Oncology, Seoul
Seoul National University Hospital - Department of Internal Medicine, Seoul
Severance Hospital, Yonsei University Health System - Medical Oncology, Seoul
Hospital Universitario Vall d'Hebrón, Barcelona
Hospital General Universitario Gregorio Marañón, Madrid
Hospital Universitario Ramón y Cajal, Madrid
Hospital Universitari i Politecnic La Fe, Valencia
Bristol Haematology and Oncology Centre, Bristol
Guys And St Thomas Hospital, London
Kings College Hospital - Oncology, London
Royal Free Hospital, London, London
Weston Park Hospital, Sheffield
Lead Sponsor
Advanced Accelerator Applications
INDUSTRY