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)
| Trial Status | Closed to Patient Entry |
|---|---|
| Dates |
Date of activation: 04-Feb-2015 Date Step1 close: 30-Nov-2021 Date Step2 close: 30-Nov-2021 |
| 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 - Fondazione Istituto Nazionale dei Tumori, Milano Christine Bourguignon (Clinical Operations Assistant) , EORTC Headquarters, Brussels Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels Anne-Sophie Govaerts (Clinical Scientist) , EORTC Headquarters, Brussels Ana Joaquim (Clinical Research Physician) , EORTC Headquarters, Brussels David Ndah Aki (Clinical Operations Manager) , EORTC Headquarters, Brussels Axelle Nzokirantevye (Data Manager) , EORTC Headquarters, Brussels Miriam Presas (Junior RAM) , EORTC Headquarters, Brussels Denisse Tubay (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Egle Venslovaite (Project Manager) , EORTC Headquarters, Brussels Yuliya Vostrikova (Clinical Data Expert) , EORTC Headquarters, Brussels Xiao Mang Zhou (Junior RAM) , EORTC Headquarters, Brussels |
| Type of cancer | Head and Neck |
| Participating groups |
EORTC Head and Neck Cancer Group UNICANCER Réseau d’Expertise Français sur les Cancers ORL Rares |
| Recruiting centers |
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 CEDEX, France) CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole (TOULOUSE CEDEX 9, France) Centre Antoine Lacassagne (NICE CEDEX 2, France) Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin (Berlin, Germany) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Gustave Roussy (VILLEJUIF CEDEX, France) IRCCS - Fondazione Istituto Nazionale dei Tumori (Milano, Italy) Institut Jules Bordet (Anderlecht, Belgium) Institut de Cancerologie de Lorraine (VANDOEUVRE LES NANCY CEDEX, France) Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (Saint Herblain CEDEX, France) Institut du Cancer de Montpellier (MONTPELLIER CEDEX 5, France) National Institute Of Oncology (Budapest, Hungary) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) Universitaetsklinikum Jena (Jena, Germany) Universitaetsklinikum Leipzig-Klinik fuer Hals-,Nasen-,Ohrenheilkunde (Leipzig, Germany) Universitaetsklinikum Wien - AKH unikliniken (Vienna, Austria) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) University Medical Center Groningen (Groningen, Netherlands) ZNA Middelheim (Antwerpen, Belgium) |
| Protocol summary | http://clinicaltrials.gov/study/NCT01969578 |
| NCT number | NCT01969578 |
| EudraCT | 2013-000314-38 |
| Financial Support | External Grant |
