Clinical Trial Details

EORTC-1206-HNCG

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A randomised phase II study to evaluate the efficacy and safety of Chemotherapy (CT) vs androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic, androgen receptor (AR) expressing, salivary gland cancer (SGCs)

Study documentation Publications

Trial Status Recruiting
Dates Date of activation: 04-Feb-2015
Data management at EORTC Yes
Design Phase 2
Randomized open label
Targeted Sample size EORTC Groups: 114 - All Groups: 152
Treatment Drug
Bicalutamide, Carboplatin, Cisplatin, Doxorubicin, Paclitaxel, Triptorelin
Study Staff Lisa Licitra (Study Coordinator) , IRCCS - Istituto Nazionale dei Tumori, Milano
Mihaela Balanescu (Junior RAM) mihaela.balanescu (at) eortc.org, EORTC Headquarters, Brussels
Christine Bourguignon (Clinical Operations Assistant) christine.bourguignon (at) eortc.org, EORTC Headquarters, Brussels
Catherine Fortpied (Statistician) catherine.fortpied (at) eortc.org, EORTC Headquarters, Brussels
Sofia Gomes (Clinical Operations Manager) sofia.gomes (at) eortc.org, EORTC Headquarters, Brussels
Anne-Sophie Govaerts (Clinical Scientist) anne-sophie.govaerts (at) eortc.org, EORTC Headquarters, Brussels
Leslie Herman (Regulatory Affairs Manager) leslie.herman (at) eortc.org, EORTC Headquarters, Brussels
David Ndah Aki (Junior Clinical Operations Manager) david.ndahaki (at) eortc.org, EORTC Headquarters, Brussels
Axelle Nzokirantevye (Data Manager) axelle.nzokirantevye (at) eortc.org, EORTC Headquarters, Brussels
Tiana Raveloarivahy (Data Manager) tiana.raveloarivahy (at) eortc.org, EORTC Headquarters, Brussels
Bette Stofs (Pharmacovigilance Manager) bette.stofs (at) eortc.org, EORTC Headquarters, Brussels
Claudia Tomas (Project Manager) claudia.tomas (at) eortc.org, EORTC Headquarters, Brussels
Maureen Vanlancker (Clinical Research Physician) maureen.vanlancker (at) eortc.org, EORTC Headquarters, Brussels
Type of cancer Head and Neck
Participating groups EORTC Head and Neck Cancer Group
UNICANCER
Alliance
IRCI UK Salivary Gland Cancer Group
Réseau d’Expertise Français sur les Cancers ORL Rares
Recruiting centers Amsterdam UMC - locatie VUMC (Amsterdam, Netherlands)
Assistance Publique - Hopitaux de Paris - Hopital Tenon (Paris, France)
Athens University - Attikon University General Hospital (Athens, Greece)
Azienda Ospedaliera Papa Giovanni XXIII (Bergamo, Italy)
Azienda Provinciale per i Servizi Sanitari - Ospedale Santa Chiara (Trento, Italy)
CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre (Bordeaux, France)
CHU de Nantes - Hotel Dieu (Nantes, France)
Centre Antoine Lacassagne (Nice, France)
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin (Berlin, Germany)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Gustave Roussy (Villejuif, France)
IRCCS - Istituto Nazionale dei Tumori (Milano, Italy)
Institut Claudius Regaud - IUCT oncopole (Toulouse, France)
Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium)
Institut de Cancerologie de Lorraine (Vandoeuvre-Les-Nancy, France)
Institut de Cancerologie de l’Ouest (ICO) - Centre Rene Gauducheau (Nantes - St. Herblain, France)
Institut du Cancer de Montpellier (Montpellier, France)
National Institute Of Oncology (Budapest, Hungary)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
Universitaetsklinikum Jena (Jena, Germany)
Universitaetsklinikum Leipzig-Klinik fuer Hals-,Nasen-,Ohrenheilkunde (Leipzig, Germany)
Universitaetsklinikum Wien - AKH uniklinieken (Vienna, Austria)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
University Medical Center Groningen (Groningen, Netherlands)
ZNA Middelheim (Antwerpen, Belgium)
Centers to be activated Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy)
Clatterbridge NHS -Wirral (Wirral, United Kingdom)
Instituto Portugues de Oncologia do Porto (Porto, Portugal)
Istituto Europeo di Oncologia (Milano, Italy)
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom)
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
NHS Lothian - Western General Hospital (Edinburgh, United Kingdom)
Ospedale San Paolo (Milano, Italy)
Royal Marsden Hospital - Chelsea, London (London, United Kingdom)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
University College Hospital (London, United Kingdom)
Velindre NHS Trust - Velindre Cancer Centre (Cardiff, United Kingdom)
Protocol summary http://clinicaltrials.gov/ct/show/NCT01969578
NCT number NCT01969578
EudraCT 2013-000314-38