Symptoms and General Pathology

All Conditions

Neoplasms

Mouth and Tooth Diseases

Rare Diseases

Recurrence

Adenocarcinoma

Salivary Gland Neoplasms

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Kennedy Disease

Oral Cancer

Antineoplastic Agents

All Drugs and Chemicals

Reproductive Control Agents

Anti-Infective Agents

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Androgens

Doxorubicin

Liposomal doxorubicin

Cisplatin

Triptorelin Pamoate

Bicalutamide

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Androgen Antagonists

Hormones

Hormone Antagonists

Contraceptive Agents

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Antineoplastic Agents, Hormonal

Chemotherapy = either Cisplatin + Doxorubicin or Carboplatin + Paclitaxel

Patients from cohort A (chemonaïve) may be randomized in this arm to receive chemotherapy

ADT = bicalutamide + triptorelin

Patients from cohort A (chemonaive) may be randomized to receive ADT, and patients from cohort B (pre-treated) will receive ADT without having been randomized.

bicalutamide + triptorelin

Cisplatin + Doxorubicin

Carboplatin + Paclitaxel

Lisa Licitra

Kevin Harrington

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.

Androgen Deprivation Therapy in Advanced Salivary Gland Cancer

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)

adverse events will be recorded using International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, the investigator will assess whether those events are drug related (reasonable possibility, no reasonable possibility) and this assessment will be recorded in the database for all adverse events

European Organisation for Research and Treatment of Cancer - EORTC

Spots Global Cancer Trial Database for adenocarcinoma, nos