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Spots Global Cancer Trial Database for Androgen Deprivation Therapy in Advanced Salivary Gland Cancer

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Lisa Licitra

Affiliation: Fondazione IRCCS ISTITUTO NAZIONALE TUMORI

Role: PRINCIPAL_INVESTIGATOR

Name: Kevin Harrington

Affiliation: The Royal Marsden

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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