About this trial
This is a phase II randomized trial, where patients with histologically proven squamous cell carcinoma of oropharynx that have primary tumor (T3 - T4) in place, treated with curative intent chemoradiation, will be randomized to systematic mid-treatment MRI-based radiotherapy adaptation vs. standard of care. The primary objective is to compare patient-rated dysphagia (as assessed by the MD Anderson Dysphagia Inventory composite score at 6 months post-treatment in patients undergoing routine mid-treatment MR-guided radiotherapy adaptation vs. in patients receiving the current standard of care.
Eligibility criteria
Qualifiers
Age ≥18 years
Ability to provide written informed consent.
Stage T3-T4N0-3 as per AJCC 8th edition
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Disqualifiers
Previous irradiation of the head and neck (HNC) region, excluding superficial radiation therapy for non-melanomatous skin cancer
Previous surgery of the HNC region (except for incisional or excisional biopsies)
Pregnancy or breastfeeding
Connective tissue disease
Trial design
Treatments tested in this trial
- Standard radiotherapy +/- chemotherapy
- Experimental radiotherapy +/- chemotherapy
Treatment groups
Sponsors and collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
Austin Health
Collaborator