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Brief Title: Androgen Deprivation Therapy in Advanced Salivary Gland Cancer
Official Title: A Randomized 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 ID: NCT01969578
Brief Summary: Salivary Gland (SG) Cancers are a rare and heterogeneous group of tumors, usually approached by multidisciplinary teams in high specialized centers. Until today no standard of care exists to treat these cancers. The identification of a target, the androgen receptor, in SG tumors has allowed for new treatment strategies options for this rare group of diseases. As a matter of fact, strong positivity for androgen expression has been found in salivary duct carcinoma and adenocarcinomas. The purpose of this study is therefore to evaluate the efficacy and safety of chemotherapy versus androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic AR expressing SGCs. The study will include two cohorts of patients: Cohort A, which comprises chemo-naïve patients, and Cohort B, which comprises pretreated patients.
Detailed Description: Patients in Cohort A will be randomized 1:1 at the study entry to receive ADT (triptorelin + bicalutamide 50 mg) or standard chemotherapy. Patients of Cohort A randomized to the control arm (chemotherapy arm) will be given the option to enter Cohort B at the time of disease progression. As long as Cohort A is open to recruitment, patients who will be treated by chemotherapy will be simultaneously enrolled in Cohort B. Accrual in Cohort B will be stopped when recruitment of 76 eligible patients in Cohort A is reached.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medical University Vienna - General Hospital AKH, Vienna, , Austria
ZNA Middelheim, Antwerp, , Belgium
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
U.Z. Leuven - Campus Gasthuisberg, Leuven, , Belgium
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre, Bordeaux, , France
Institut régional du Cancer Montpellier, Montpellier, , France
Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau, Nantes, , France
CHU de Nantes - Hotel Dieu, Nantes, , France
Centre Antoine Lacassagne, Nice, , France
Assistance Publique - Hopitaux de Paris - Hopital Tenon, Paris, , France
Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole - Institut Claudius Regaud, Toulouse, , France
Institut de Cancérologie de Lorraine, Vandoeuvre-Les-Nancy, , France
Gustave Roussy, Villejuif, , France
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin, , Germany
Universitaetsklinikum Jena-Radiation Therapy and Radiooncology Clinic, Jena, , Germany
Universitaetsklinikum Leipzig-Ambulanzen/Sprechstunden, Leipzig, , Germany
Athens University - Attikon University General Hospital, Athens, , Greece
National Institute Of Oncology, Budapest, , Hungary
Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, , Italy
Azienda Provinciale per i Servizi Sanitari - Ospedale Santa Chiara, Trento, , Italy
Spaarne Gasthuis - Vrije Universiteit Medisch Centrum, Amsterdam, , Netherlands
University Medical Center Groningen (UMCG), Groningen, , Netherlands
Radboud University Medical Center Nijmegen, Nijmegen, , Netherlands
Name: Lisa Licitra
Affiliation: Fondazione IRCCS ISTITUTO NAZIONALE TUMORI
Role: PRINCIPAL_INVESTIGATOR
Name: Kevin Harrington
Affiliation: The Royal Marsden
Role: STUDY_CHAIR