Clinical Trial Details

EORTC-1206-HNCG

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