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Brief Title: A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours
Official Title: A Multicentre, Stratified, Open, Randomized, Comparator-controlled, Parallel-group Phase III Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours
Study ID: NCT01578239
Brief Summary: This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutathera plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in participants with metastasized or locally advanced, inoperable, somatostatin receptor positive, histologically proven midgut carcinoid tumours with progression despite LAR treatment.
Detailed Description: After the screening period, participants who signed the ICF and were eligible for the study in accordance with the entry criteria were randomly assigned to treatment either Lutathera or Octreotide LAR. Participant randomization was performed according to a centralized permuted block randomization scheme with a balanced ratio (1:1) between the 2 treatment groups, stratified by tumor uptake score and by the length of time that a participant was on a constant dose of Octreotide (=\< 6 versus \> 6 months). Objective tumor assessment in both groups was performed every 12+/-1 weeks from the randomization date according to RECIST Criteria until progression was centrally confirmed: 1. Any participants with progressive disease (confirmed by central review of CT/MRI scans) ceased the treatment/assessment period and proceeded to the long-term follow-up period for evaluation of survival and long-term safety. 2. All non-progressive participants continued treatment/assessments until the PFS primary endpoint was met (i.e. 74 evaluable and centrally confirmed disease progressions or death events). Once the Primary End-Point was reached: 1. Participants who received more than 76 weeks of treatment/assessment, stopped the study treatment (however somatostatin analogues could be received as subsequent treatment as per Investigator's discretion) but continued the long-term follow-up assessment for 5 years overall from the date of randomization of the last participant randomized. 2. The remaining randomized participants continued in the fixed 76-week treatment/assessment period unless progression occurred, then continued the long-term follow-up assessments for 5 years overall from the date of randomization of the last participant.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cedars-Sinai Medical Center Samuel Oschin Cancer Center, Los Angeles, California, United States
Stanford Cancer Center, Palo Alto, California, United States
Moffitt Cancer Center, Tampa, Florida, United States
Northwestern Medical Faculty Foundation, Chicago, Illinois, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Duke University Medical Center, Durham, North Carolina, United States
Kettering Medical Center, Kettering, Ohio, United States
Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
Henry-Joyce Cancer Clinic, Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Excel Diagnostics and Nuclear Oncology Center, Houston, Texas, United States
Digestive Oncology, Leuven Cancer Institute, Leuven, Brabant Flamand, Belgium
Institut Gustave Roussy, Villejuif Cedex, Ile De France, France
Institut Claudius Regaud, Toulouse, Midi-Pyrénées, France
Hotel Dieu/CHU Nantes, Nantes, Pays De La Loire, France
Hôpital la Timone /CHU Marseille, Marseille, Provence-Alpes-Côte d'Azur, France
Centre Hospitalier Lyon-Sud, Lyon, Rhône-Alpes, France
Hôpital Beaujon AP-HP, Clichy Cedex, , France
Klinikum Rechts Isar, Nuclear Medicine, Munich, Bayern, Germany
Universitätsmedizin Mainz, Medizinische Klinik I Schwerpunkt Endokrinologie, Mainz, Rheinland-Pfalz, Germany
Zentralklinik Bad Berka, Bad Berka, Thüringen, Germany
Charité, Virchow-Klinikum, Gastroentrology, Hepatology & Endocrinology, Berlin, , Germany
Istituto Oncologico Romagnolo per lo Studio dei Tumori, Meldola, Emilia-Romagna, Italy
IEO Istituto Europeo di Oncologia, Milano, Lombardia, Italy
Presidio Osp. Di Macerata, Macerata, Marche, Italy
Azienda Ospedaliero - Universitaria Pisana (Presidio Ospedaliero S. Chiara), Pisa, Toscana, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Università "Sapienza" di Roma, Facoltà di Medicina e Psicologia, Ospedale S. Andrea-Roma, Roma, , Italy
Centro Hospitalar e Universitario de Coimbra, Coimbra, Centro, Portugal
Instituto Português de Oncologia, Porto, Norte, Portugal
University Hospital of Bellvitge, Hospitalet de Llobregat (Barcelona), Cataluña, Spain
Ramon y Cajal University Hospital, Madrid, , Spain
University of Oxford, Oxford, South East England, United Kingdom
Beatson Oncology Centre, Glasgow, , United Kingdom
Royal Free Hospital, London, , United Kingdom
Imperial College Healthcare Trust, Hammersmith Hospital, London, , United Kingdom
The Christie NHS foundation Trust, Manchester, , United Kingdom
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR