Clinical Trial Details
EORTC-1414-GUCG-ROG
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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 |
Pedro Lara (Study Coordinator) , San Roque University Hospital, Las Palmas de Gran Canaria Mihaela Balanescu (Junior RAM) , EORTC Headquarters, Brussels Jessica Berger (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Dirk Boehmer (Study Co-Coordinator) , Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin Ilse Coppens (Clinical Operations Assistant) , EORTC Headquarters, Brussels Coreen Corning (QART Manager) , EORTC Headquarters, Brussels Laura Decubber (Data Manager) , EORTC Headquarters, Brussels Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels Belma Malanda (Project Manager) , EORTC Headquarters, Brussels Salvatore Mazza (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels David Ndah Aki (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels Miguel Remis (Lead CRA) , EORTC Headquarters, Brussels Martin Spahn (Study Co-Coordinator) , Hirslanden Klinik Zurich, Zurich Eliza Starczewska (Junior RAM) , EORTC Headquarters, Brussels Bertrand Tombal (Study Co-Coordinator) , Cliniques Universitaires Saint-Luc, Brussels Laurens Vinckier (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Thomas Zilli (Study Co-Coordinator) , Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie, Geneve Gaetan de Schaetzen (Senior Clinical Operations Manager) , 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) AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium) Assistance Publique - Hopitaux de Paris - CHU Henri Mondor (Creteil, France) Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere (PARIS CEDEX 13, France) Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy) CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium) CHU de Grenoble - La Tronche - Hopital A. Michallon (GRENOBLE CEDEX 9, France) Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (Bayonne, France) Centre Georges-Francois-Leclerc (DIJON CEDEX, France) Centre Leon Berard (Lyon, France) Centre de Radiotherapie Pierre Curie (Beuvry, France) Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin (Berlin, Germany) Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (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) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Complejo Hospitalario de Navarra (Pamplona, Spain) Fundacion Hospital Alcorcon (Alcorcon - Madrid, Spain) GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium) Hopital Universitaires Erasme (Brussels, Belgium) Hospital Alvaro Cunqueiro (Vigo, Spain) Hospital Consorci Sanitari De Terrassa (Terrassa, Spain) Hospital General Universitario Santa Lucia (Cartagena, Spain) Hospital Universitario Reina Sofia (Cordoba, Spain) Hospital Universitario Virgen De La Victoria (Malaga, 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) IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" (Meldola, Italy) Inselspital (Bern, Switzerland) Institut Jules Bordet (Anderlecht, Belgium) Institut de Cancerologie de l’Ouest (ICO) - Angers (ANGERS CEDEX 02, France) Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (ST HERBALAIN CEDEX, France) Northern Lincolnshire and Goole Hospitals NHS Foundation Trust - Scunthorpe General Hospital (Scunthorpe, United Kingdom) Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom) Oncology Institute of Southern Switzerland - Ospedale San Giovanni (Bellinzona, Switzerland) Otto-Von-Guericke-Universitaet Magdeburg - Universitaetsklinik (Magdeburg, Germany) Parc Tauli Hospital Universitari (Sabadell Barcelona, Spain) Pole Hospitalier Jolimont (Haine St Paul, Belgium) Pole Hospitalier Jolimont (Haine St Paul, Belgium) Rigshospitalet (Copenhagen, Denmark) Universitaetsklinikum Freiburg (Freiburg, Germany) Universitair Ziekenhuis Brussel (Brussels, Belgium) |
| Centers to be activated |
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust - Diana, Princess of Wales Hospital (Grimsby, United Kingdom) San Roque University Hospital (Las Palmas de Gran Canaria, Spain) |
| Protocol summary | http://clinicaltrials.gov/ct/show/NCT02799706 |
| NCT number | NCT02799706 |
| EudraCT | 2015-005098-19 |
| Financial Support | Educational Grant |
