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 | Closed to Patient Entry |
|---|---|
| Dates |
Date of activation: 25-Sep-2017 Date Step1 close: 06-Feb-2023 |
| Data management at EORTC | Yes |
| Design |
Phase 3 Randomized open label |
| Targeted Sample size | EORTC Groups: 885 - All Groups: 885 |
| Treatment |
Radiotherapy, Drug Goserelin, Triptorelin, Leuprorelin, Degarelix |
| Study Staff |
Pedro Lara (Study Coordinator) , San Roque University Hospital, Las Palmas de Gran Canaria Jessica Berger (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Isabelle Blangenois (Data Manager) , 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 David D'Haese (Statistician) , EORTC Headquarters, Brussels Jozefien Debruyne (Junior PVM) , EORTC Headquarters, Brussels Laura Decubber (Data Manager) , EORTC Headquarters, Brussels Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels Amaya Gonzalez (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Lore Hermans (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Belma Malanda (Project Manager) , EORTC Headquarters, Brussels David Ndah Aki (Clinical Operations Manager) , EORTC Headquarters, Brussels Daniel Portik (Medical Fellow) , 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 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 |
APHP - Hop. Univ. Henri Mondor (Creteil, France) APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (PARIS, France) AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium) 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) Complejo Hospitalario de Navarra (Pamplona, Spain) GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium) Hopital Universitaires Erasme (Brussels, Belgium) Hopitaux universitaires de Geneve - HUG - site de Cluse-Roseraie (Geneve, Switzerland) Hopitaux universitaires de Geneve - HUG - site de Cluse-Roseraie (Geneve, Switzerland) Hospital Alvaro Cunqueiro (Vigo, Spain) Hospital Consorci Sanitari De Terrassa (Terrassa, Spain) Hospital General Universitario Santa Lucia (Cartagena, Spain) Hospital Universitario Alcorcon (Alcorcon - Madrid, 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 - Hosp Virgen De la Vega (Salamanca, Spain) 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 (Saint Herblain CEDEX, France) Northern Lincolnshire and Goole Hospitals NHS Foundation Trust - Diana, Princess of Wales Hospital (Grimsby, United Kingdom) 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 - Hopital Jolimont (Haine-Saint-Paul, Belgium) Pole Hospitalier Jolimont - Hopital Jolimont (Haine-Saint-Paul, Belgium) Rigshospitalet (Copenhagen, Denmark) Universitaetsklinikum Freiburg (Freiburg, Germany) Universitair Ziekenhuis Brussel (Brussels, Belgium) |
| Protocol summary | http://clinicaltrials.gov/ct/show/NCT02799706 |
| NCT number | NCT02799706 |
| EudraCT | 2015-005098-19 |
| Financial Support | Educational Grant |
