Adaptive RadioTherapy for OroPharynx Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

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

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators