EORTC1206 Salivary Gland Study
Research type
Research Study
Full 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).
IRAS ID
156432
Contact name
Kevin Harrington
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer (EORTC)
Eudract number
2013-000314-38
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
ICR/CTSU/2013/10043 , ICR-CTSU protocol number for UK specific appendix
Duration of Study in the UK
5 years, 4 months, 4 days
Research summary
Salivary Gland Carcinomas (SCGs) are rare, comprising fewer than 5% of all cancers of the head and neck region. This rarity means that there are few prospective clinical trials investigating its management. SGCs can be locally aggressive, invading facial nerve, skin, bone and surrounding soft tissue. Recurrent and metastatic SGCs are commonly treated with chemotherapy but there is limited clinical trial data to define the role of chemotherapy in these patients. Recent studies have shown that the spread and growth of some SGCs is stimulated by male growth hormones (androgens); these types of SGC are known as androgen receptor positive (AR+) and may respond to drugs that lower or block the supply of androgens (androgen deprivation therapy (ADT)). The aim of this study is to assess the potential of ADT in patients with relapsed and/or metastatic AR+ SGC.
This is an international, multicentre, randomised phase II study consisting of two patient cohorts: Cohort A which comprises patients not previously treated with chemotherapy and Cohort B which comprises patients who have progressed on standard chemotherapy. AR+ patients in Cohort A will be randomised 1:1 to receive ADT (triptorelin and bicalutamide) or standard (control) chemotherapy ie cisplatin/doxorubicin or carboplatin/ paclitaxel. All patients in Cohort B will receive ADT. Patients in the chemotherapy arm of Cohort A may enter Cohort B at the time of disease progression. The aim is to enrol 152 participants globally, 76 into both Cohort A and B. The UK will contribute up to 30 patients in total.
An important part of EORTC1206 is the optional donation of biological samples from AR+ and AR- patients for future translational studies. Samples including tissue from diagnosis/progression, blood and saliva will be collected during the study and used to focus on understanding the mechanisms of AR expression and hormone sensitivity/resistence.REC name
London - Westminster Research Ethics Committee
REC reference
15/LO/1581
Date of REC Opinion
22 Jan 2016
REC opinion
Further Information Favourable Opinion