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.

The trial will evaluate the efficacy and safety of the targeted radiopharmaceutical 177Lu-Edotreotide compared with the standard therapy in patients with neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET).

The primary endpoint of this phase III study is to confirm improved patient survival rates without advancing tumor growth (progression-free survival). Secondary endpoints include overall survival (OS), parameters of morphological and functional tumor response, safety and health-related quality of life (HRQL). 

The study will be conducted in Europe, North America, South Africa and Australia simultaneously in 11 countries at over 33 sites. The first patient has been enrolled and treated in Australia.

How is the Study structured?

In total, 300 GEP-NET patients will be randomized 2:1 to receive either Targeted Radionuclide Therapy with 177Lu-Edotreotide consisting of a maximum of four cycles (7.5 GBq 177Lu-Edotreotide each), administered as an IV infusion at 3-month intervals for 9 months, or until diagnosis of progression (200 patients), or 10 mg Everolimus daily, administered orally as a tablet until diagnosis of progression (100 patients). Study duration per patient will be 24 months.

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 to take 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 der Stadt 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

  • LMU – Klinikum der Universität München
    Campus Großhadern
    81377 München, Germany
    Website

  • Philipps Universität Marburg
    35032 Marburg, Germany
    Website

  • UKB Universitätsklinikum Bonn
    53127 Bonn, Germany
    Website

  • UKS Universitätsklinikum des Saarlandes
    66421 Homburg, Germany
    Website

  • UKW Universitätsklinikum Würzburg
    97080 Würzburg, Germany
    Website

  • Universitätsklinikum Erlangen
    91054 Erlangen, 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

  • Jagiellonian University Hospital Krakow
    31-007 Krakow, Poland
    Website

South Africa

  • Steve Biko Academic Hospital – University of Pretoria
    Pretoria 0001, South Africa 
    Website

Switzerland

  • Inselspital – Universitätsspital Bern
    3010 Bern, Switzerland
    Website

  • Universitätsspital Basel
    4031 Basel, Switzerland
    Website

The Netherlands

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

UK

  • Royal Free London – NHS Foundation Trust
    London NW3 2QG, United Kingdom
    Website

  • The Royal Liverpool University Hospital – NHS Foundation Trust
    Liverpool L7 8XP, United Kingdom
    Website

USA

  • Excel Diagnostics & Nuclear Oncology Center
    Houston, TX 77042, USA
    Website

  • Mayo Clinic
    Rochester, MN 55905, USA
    Website

  • Moffitt Cancer Center & Research Institute
    Tampa, FL 33612, USA
    Website

  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, MI 48109, USA
    Website

  • Virginia Mason Medical Center
    Seattle, WA 98101, USA
    Website