Clinical Trial Details
EORTC-1414-ROG-GUCG
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Phase IIIb randomized trial comparing irradiation plus long term adjuvant androgen deprivation with GnRH antagonist versus GnRH agonist plus flare protection in patients with very high risk localized or locally advanced prostate cancer. A joint study of the EORTC ROG and GUCG
| Trial Status | Recruiting |
|---|---|
| Dates |
Date of activation: 25-Sep-2017 |
| Data management at EORTC | Yes |
| Design |
Phase 3 Randomized open label |
| Targeted Sample size | All Groups: 885 |
| Treatment |
Radiotherapy, Drug Degarelix, Leuprorelin acetate, Goserelin acetate, Triptorelin acetate, Triptorelin pamoate |
| Study Staff |
Dirk Boehmer (Study Coordinator) , Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin Pedro Lara (Study Coordinator) , San Roque University Hospital, Las Palmas de Gran Canaria Bertrand Tombal (Study Coordinator) , Cliniques Universitaires Saint-Luc, Brussels Kimberley Ceulemans (Lead CRA) kimberley.ceulemans (at) eortc.org, EORTC Headquarters, Brussels Laurence Collette (Statistician) laurence.collette (at) eortc.org, EORTC Headquarters, Brussels Coreen Corning (QART Manager) coreen.corning (at) eortc.org, EORTC Headquarters, Brussels Beatrice Fournier (Clinical Scientist) beatrice.fournier (at) eortc.org, EORTC Headquarters, Brussels Julie Hermans (Regulatory Affairs Manager) julie.hermans (at) eortc.org, EORTC Headquarters, Brussels Fiona Namanya (Clinical Trial Assistant) fiona.namanya (at) eortc.org, EORTC Headquarters, Brussels Miguel Remis (Clinical Research Associate/Monitor) miguel.remis (at) eortc.org, EORTC Headquarters, Brussels Nabila Sebti (Data Manager) nabila.sebti (at) eortc.org, EORTC Headquarters, Brussels Ionela Stanciu (Junior Clinical Operations Manager) ionela.stanciu (at) eortc.org, EORTC Headquarters, Brussels Eliza Starczewska (Regulatory Affairs Administrator) eliza.starczewska (at) eortc.org, EORTC Headquarters, Brussels Christophe Verstegen (Clinical Operations Manager) christophe.verstegen (at) eortc.org, EORTC Headquarters, Brussels Laurens Vinckier (Pharmacovigilance Manager) laurens.vinckier (at) eortc.org, EORTC Headquarters, Brussels |
| Type of cancer | Prostate |
| Participating groups |
EORTC Genito-Urinary Cancers Group EORTC Radiation Oncology Group |
| Recruiting centers |
AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium) Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere (Paris, France) Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy) CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium) CHU de Grenoble - La Tronche - Hôpital A. Michallon (Grenoble, France) Centre Hospitalier Privé Saint-Grégoire (Saint-Gregoire, France) Centre Leon Berard (Lyon, France) Centre de Radiotherapie Pierre Curie (Beuvry, France) Centre de radiotherapie Marie Curie (Arras, France) Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin (Berlin, Germany) Clinica IMQ Zorrotzaurre (Bilbao, Spain) Clinique Pasteur-Toulouse-Atrium (Toulouse, France) Clinique de l'Europe (Amiens, France) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Complejo Hospitalario A (Pamplona, Spain) Corporacio Sanitaria Parc Tauli (Sabadell, Spain) Fundacion Hospital Alcorcon (Alcorcon - Madrid, Spain) GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium) Hopital De Jolimont (Haine St Paul, Belgium) Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme (Brussels, Belgium) Hospital Alvaro Cunqueiro (Vigo, Spain) Hospital Universitario Reina Sofia (Cordoba, Spain) Hospital Universitario de Gran Canaria Doctor Negrin (Las Palmas de Gran Canaria, Spain) Hospital Universitario de Salamanca (Salamanca, Spain) Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie (Geneve, Switzerland) ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain) Inselspital (Bern, Switzerland) Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium) Institut de Cancerologie de l’Ouest (ICO) - Centre Rene Gauducheau (Nantes - St. Herblain, France) Krankenhaus Barmherzige Schwestern (Linz, Austria) Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli (Bellinzona, Switzerland) Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli (Bellinzona, Switzerland) Otto-Von-Guericke-Universitaet Magdeburg - Universitaetsklinik (Magdeburg, Germany) Rigshospitalet (Copenhagen, Denmark) Universitaetsklinikum Freiburg (Freiburg, Germany) Universitair Ziekenhuis Brussel (Brussels, Belgium) |
| Centers to be activated |
Assistance Publique - Hopitaux de Paris - CHU Henri Mondor (Creteil, France) Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (Bayonne, France) Centre Georges-Francois-Leclerc (Dijon, France) Centre Georges-Francois-Leclerc (Dijon, France) Centre Hospitalier Departemental Vendée (La Roche Sur Yon, France) Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (Berlin, Germany) Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom) Hirslanden Klinik Zurich (Zurich, Switzerland) Hospital Consorci Sanitari De Terrassa (Terrassa, Spain) Hospital Escolar Sao Joao (Porto, Portugal) Hospital General Universitario Santa Lucia (Cartagena, Spain) Hospital Universitario Virgen De La Victoria (Malaga, Spain) Institut de Cancerologie de l’Ouest (ICO) - Centre Paul Papin (Angers, France) Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (Meldola, Italy) Northern Lincolnshire and Goole Hospitals NHS Foundation Trust - Scunthorpe General Hospital (Scunthorpe, United Kingdom) Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom) Ospedale Niguarda Ca Granda (Milano, Italy) Universitaetsklinikum - Essen (Essen, Germany) |
| Protocol summary | http://clinicaltrials.gov/ct/show/NCT02799706 |
| NCT number | NCT02799706 |
| EudraCT | 2015-005098-19 |