A randomised phase II study to evaluate the efficacy and safety of chemotherapy versus androgen deprivation therapy in patients with recurrent and/or metastatic, androgen receptor expressing, salivary gland cancer.
Disease site: Head and neck cancer
Treatment modality: Systemic therapy
Status: In set up
EORTC1206-HNCG is an international multicentre, randomised phase II study to evaluate the efficacy and safety of chemotherapy compared with androgen deprivation therapy (ADT; triptorelin and bicalutamide) in people with recurrent and/or metastatic, androgen receptor (AR) expressing, salivary gland cancer.
The study comprises two patient cohorts:
- Cohort A, which comprises patients who previously have not been treated with chemotherapy. Patients will be randomised 1:1 to receive ADT or standard (control) chemotherapy.
- Cohort B, which comprises patients who have progressed on standard chemotherapy, will receive ADT.
The aim is to enrol 152 participants globally; 76 into cohort A (38 in each arm) and approximately the same number of patients in cohort B. The UK will contribute up to 30 patients in total.
Participants will be followed up until disease progression and yearly thereafter.
Global Chief Investigator: Dr Lisa Licitra, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
UK National Coordinating Investigator: Professor Kevin Harrington, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research
ICR-CTSU Scientific Lead: Dr Emma Hall
UK trial management contact: [email protected]
Sponsor: European Organisation for Research and Treatment of Cancer (EORTC)
Funding: EORTC, Belgium; Bluefish Pharmaceuticals AB, Sweden; and Cancer Research UK (CRUK/13/016)
Publications and presentations
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