Adaptive RadioTherapy for OroPharynx Cancer

Summary

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

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Conditions6

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