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The COMPETE Trial

The phase III clinical trial COMPETE is led as an international, prospective, randomized, controlled, open-label, multicenter (conducted in multiple countries simultaneously) phase III study. This means, that during the study new data will be collected (prospective), that patients are randomly allocated to receive either no-carrier-added Lutetium-177-Edotreotide (n.c.a. 177Lu-Edotreotide) or the current standard of care (randomized) and that results in patients receiving the investigational treatment are compared to a control group receiving the standard therapy (controlled). Additionally, patients and physicians know which drug is being administered (open-label) and the study is conducted at multiple sites in multiple countries simultaneously (multicenter).

The trial will evaluate the efficacy and safety of the targeted radiopharmaceutical n.c.a. 177Lu-Edotreotide compared to the standard therapy Everolimus in patients with neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NETs). The treatment option for NETs being investigated in this trial is called Targeted Radionuclide Therapy (also known as Peptide Receptor Radionuclide Therapy / PRRT). It is not to be confused with traditional radiation therapy, which irradiates tumors from the outside of the body.

The primary objective is to demonstrate the efficacy of Targeted Radionuclide Therapy with n.c.a. 177Lu-Edotreotide to prolong median progression-free survival (mPFS) in patients with inoperable, progressive, somatostatin receptor positive (SSTR+) GEP-NETs, compared to Everolimus. Key secondary objectives are to assess objective response rates (ORR), defined as the proportion of patients achieving partial response (PR) or complete response (CR) as best outcome, after treatment with n.c.a. 177Lu-Edotreotide compared to Everolimus and to assess overall survival (OS).

The study is currently being conducted in Europe, North America, South Africa and Australia simultaneously in 12 countries at over 43 sites. The first patient was enrolled and treated in Australia.

How is the study structured?

300 GEP-NETs patients will be randomized 2:1. Neither the patient nor the doctor will be able to decide which group the patients are in. It is two times more likely that the patient will receive Targeted Radionuclide Therapy with n.c.a. 177Lu-Edotreotide than the standard therapy with Everolimus.

200 Patients: Targeted Radionuclide Therapy with n.c.a. 177Lu-Edotreotide with a maximum of 4 cycles, administered as an infusion at 3-monthly intervals for 9 months, or until diagnosis of progression

100 Patients: Everolimus, 10 mg daily, administered orally as a tablet
 

Study Duration
24 months / patient

Study Conduction
Europe, North America, South Africa and Australia, min.12 countries and approx. 43 sites

Who can participate?

The following criteria must be fulfilled:

  • Male or female ≥ 18 years of age 
  • Well-differentiated neuroendocrine tumor of gastroenteric or pancreatic origin (GE-NET), tumor grade G1 or G2, unresectable or metastatic 
  • Available existing biopsy specimen from primary tumor or metastasis or, if unavailable, willingness to undergo current biopsy for secondary central analysis
  • Measurable disease with ≥ 1 lesion of ≥ 1 cm in diameter, and ≥ 2 radiological tumor lesions in total. A maximum of 5 visible target lesions, not more than 2 lesions per organ 
  • Somatostatin receptor positive (SSTR+) target lesions and non-target lesions 
  • Progressive disease 
  • Karnofsky performance status (KPS) scale ≥ 70 
  • Life expectancy of at least 6 months 
  • Glomerular filtration rate (GFR, MDRD) ≥ 60 mL/min/1.73 m2 

Participating clinical centers

If you are interested in taking part in the COMPETE study, please contact your attending doctor or a participating study center nearby:

 

Australia

  • Austin Health, Centre for PET
    Heidelberg VIC 3084, Australia
    Website
     
  • Fiona Stanley Hospital
    Murdoch / Perth WA 6150, Australia
    Website
     
  • Peter MacCallum Cancer Centre
    Melbourne VIC 3000, Australia
    Website
     
  • Royal North Shore Hospital
    St Leonards / Sydney NSW 2065, Australia
    Website

Austria

  • Allgemeines Krankenhaus Wien
    Medizinischer Universitätscampus
    1090 Wien, Austria
    Website

France

  • CHU de Nantes – Hôtel Dieu
    44093 Nantes, France
    Website
     
  • Hôpital Beaujon
    University Hospital North Paris Val-de-Seine
    92110 Clichy, France
    Website
     
  • Hospices Civils de Lyon
    69002 Lyon, France
    Website
     
  • Institut de Recherche en Cancérologie de Montpellier (IRCM)
    34298 Montpellier, France
    Website

Germany

  • Charité – Universitätsmedizin Berlin
    10117 Berlin, Germany
    Website
     
  • Philipps Universität Marburg
    35032 Marburg, Germany
    Website
     
  • UKB Universitätsklinikum Bonn
    53127 Bonn, Germany
    Website
     
  • UKW Universitätsklinikum Würzburg
    97080 Würzburg, Germany
    Website
     
  • Universitätsklinikum Erlangen
    91054 Erlangen, Germany
    Website
     
  • Universitätsklinikum Magdeburg A.ö.R.
    Otto-von-Guericke Universität
    39120 Magdeburg, Germany
    Website
     
  • Universitätsklinikum Ulm
    89081 Ulm, Germany
    Website
     
  • Zentralklinik Bad Berka GmbH
    99437 Bad Berka, Germany
    Website

Italy

  • European Institute of Oncology (IEO)
    20141 Milan, Italy
    Website
     
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
    47014 Meldola (FC), Italy
    Website

Poland

  • Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie
    44-101 Gliwice, Poland
    Website

South Africa

  • Steve Biko Academic Hospital – University of Pretoria
    Pretoria 0001, South Africa 
    Website
  • University Cape Town (UCT), Groote Schuur Hospital
    Cape Town 7925, South Africa
    Website

Spain

  • Vall d’Hebron University Hospital
    08035 Barcelona, Spain
    Website
     
  • Hospital MD Anderson Cancer Center Madrid
    28033 Madrid, Spain
    Website

Switzerland

  • Inselspital – Universitätsspital Bern
    3010 Bern, Switzerland
    Website
     
  • Kantonsspital St. Gallen
    9007 St. Gallen, Switzerland
    Website
     
  • Universitätsspital Basel
    4031 Basel, Switzerland
    Website
     
  • Universitätsspital Zürich
    8091 Zürich, Switzerland
    Website

The Netherlands

  • AMC Academic Medical Center
    1105 AZ Amsterdam, The Netherlands
    Website

UK

  • Gartnavel General Hospital
    Glasgow G12 0YN, UK
    Website
     
  • Kings College Hospital NHS Foundation Trust
    London SE5 9RS, UK
    Website
     
  • Royal Free London – NHS Foundation Trust
    London NW3 2QG, United Kingdom
    Website
     
  • Queen Elizabeth Hospital
    Birmingham B15 2TH, UK
    Website

USA

  • Excel Diagnostics & Nuclear Oncology Center
    Houston, TX 77042, USA
    Website
     
  • MD Anderson Cancer Center, Banner Health
    Gilbert, AZ 85234, USA
    Website
     
  • Moffitt Cancer Center & Research Institute
    Tampa, FL 33612, USA
    Website
     
  • Stanford University, Nuclear Medicine and Molecular Imaging
    Stanford, CA 94305, USA
    Website
     
  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, MI 48109, USA
    Website
     
  • Virginia Mason Medical Center
    Seattle, WA 98101, USA
    Website