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Androgen Deprivation Therapy in Advanced Salivary Gland Cancer

NCT01969578 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2024-11-05

No results posted yet for this study

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.

Conditions

  • Salivary Gland Cancer

Interventions

DRUG

bicalutamide + triptorelin

DRUG

Cisplatin + Doxorubicin

DRUG

Carboplatin + Paclitaxel

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Lisa Licitra · Fondazione IRCCS ISTITUTO NAZIONALE TUMORI

  • Kevin Harrington · The Royal Marsden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-24
Primary Completion
2023-08-23
Completion
2024-02-16

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01969578 on ClinicalTrials.gov