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Spots Global Cancer Trial Database for A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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