Adaptive RadioTherapy for OroPharynx Cancer

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.
• Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx.
• Planned for curative radiotherapy +/- chemotherapy
• For females of child-bearing age, a negative pregnancy test
• Patients treated with induction chemotherapy can be included if they have residual tumor in place.

🚫 You may not be able to join if…

• 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
• Any medical condition that could, in the opinion of the investigator, prevent follow-up after radiotherapy.
• Patients with contra-indications to MRI will be excluded.

Where this trial is running

• Austin Health, Melbourne, Australia
• Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada