Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma 2
Status:
Recruiting
Trial end date:
2021-08-01
Target enrollment:
Participant gender:
Summary
This is a single-centre feasibility study designed to assess the safety, tolerability and
engraftment of MET-4 bacterial strains when given in combination with chemoradiotherapy
(CRT). The study will involve a prospective cohort of 30 patients diagnosed with
Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (LA-OPSCC) to be treated with
CRT as per standard of care at Princess Margaret Cancer Centre. All patients enrolled will
receive MET-4 in addition to standard CRT. MET-4 is administered orally as an initial daily
loading dose over 2 days followed by a daily maintenance dose of MET-4 and will be
administered until week 4 of CRT or unacceptable toxicity whichever occurs earlier and in the
absence of criteria to discontinue MET-4. This protocol does not determine eligibility to
receive treatment with concurrent CRT. It is anticipated that patient accrual will be
completed within 12 months.