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 Dirk Boehmer (Study Co-Coordinator) , Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin Coreen Corning (QART Manager) , EORTC Headquarters, Brussels Pierre-Edouard Dollet (Project Manager) , EORTC Headquarters, Brussels Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels Joanna Krzystyniak (Clinical Operations Manager) , EORTC Headquarters, Brussels Fiona Namanya (Clinical Operations Assistant) , EORTC Headquarters, Brussels David Ndah Aki (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels Anouk Neven (Statistician) , EORTC Headquarters, Brussels Miguel Remis (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Nabila Sebti (Data Manager) , 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 Christine de Balincourt (Lead CRA) , 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 - Hopital A. Michallon (Grenoble, France) Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (Bayonne, France) Centre Georges-Francois-Leclerc (Dijon, France) Centre Hospitalier Prive Saint-Gregoire (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) 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) Complejo Hospitalario de Navarra (Pamplona, Spain) Corporacio Sanitaria Parc Tauli (Sabadell Barcelona, Spain) Fundacion Hospital Alcorcon (Alcorcon - Madrid, Spain) GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium) Hopital De Jolimont (Haine St Paul, Belgium) Hopital De Jolimont (Haine St Paul, 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-Hopital Universitaire ULB (Brussels, Belgium) Institut de Cancerologie de l’Ouest (ICO) - Centre Paul Papin (Angers, France) Institut de Cancerologie de l’Ouest (ICO) - Centre Rene Gauducheau (Nantes - St. Herblain, 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) 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 Saint-Yves (Vannes, France) Hirslanden Klinik Zurich (Zurich, Switzerland) Ospedale Niguarda Ca Granda (Milano, Italy) San Roque University Hospital (Las Palmas de Gran Canaria, Spain) Universitaetsklinikum - Essen (Essen, Germany) |
| Protocol summary | http://clinicaltrials.gov/ct/show/NCT02799706 |
| NCT number | NCT02799706 |
| EudraCT | 2015-005098-19 |
| Financial Support | Educational Grant |