Study

EORTC-1414-GUCG-ROG

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

Study documentation Back to result

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
  • Dirk Boehmer (Study Co-Coordinator, Study Co-Coordinator, 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
  • Jozefien Debruyne (Junior PVM), EORTC Headquarters, Brussels
  • Catherine Fortpied (Statistician), EORTC Headquarters, Brussels
  • Beatrice Fournier (Clinical Scientist), EORTC Headquarters, Brussels
  • Lore Hermans (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Belma Malanda (Project Manager), EORTC Headquarters, Brussels
  • Bart Meulemans (Data Manager), EORTC Headquarters, Brussels
  • Zara Nasir (Pharmacovigilance 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
  • Jelle Stans (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Eliza Starczewska (Junior RAM), EORTC Headquarters, 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)
  • CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont (Haine-Saint-Paul, Belgium)
  • 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 Cedex 3, France)
  • Clinique Victor Pauchet (Amiens, France)
  • Cliniques Universitaires Saint-Luc (Brussels, Belgium)
  • Complejo Hospitalario de Navarra (Pamplona, Spain)
  • GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium)
  • HUB-Hopital Universitaires Erasme (Brussels, Belgium)
  • 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 Fundacion 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)
  • Rigshospitalet (Copenhagen, Denmark)
  • Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy)
  • Universitaetsklinikum Freiburg (Freiburg, Germany)
  • Universitair Ziekenhuis Brussel (Brussels, Belgium)

Protocol summary

http://clinicaltrials.gov/study/NCT02799706

NCT number

NCT02799706

EudraCT

2015-005098-19