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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
149
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
...and 16 more locations
Progression Free Survival (PFS)
PFS is a primary outcome for cohort A
Time frame: 37 months after First Patient In
Response rate (RR)
RR is a primary outcome for cohort B
Time frame: 37 months after First Patient In
Response Rate (RR)
RR is a secondary outcome for cohort A
Time frame: 37 months after First Patient In
Progression Free Survival (PFS)
PFS is a secondary outcome for cohort B
Time frame: 37 months after First Patient In
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