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Recruiting
NCT04901234
Adaptive RadioTherapy for OroPharynx Cancer
Conditions: Oropharynx Cancer, Radiotherapy; Complications, Radiotherapy Side Effect, Dysphagia, MRI
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 120
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Location: Austin Health Melbourne
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 Criteria
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.
Source: ClinicalTrials.gov (NCT04901234). StuddyBuddy aggregates publicly available trial information.