Status:
RECRUITING
Adaptive RadioTherapy for OroPharynx Cancer
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Austin Health
Conditions:
Oropharynx Cancer
Radiotherapy; Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 chemoradia...
Detailed Description
Background: Dysphagia was shown to be the main driver of adverse quality of life after head and neck radiotherapy. Over the 7-week radiotherapy course, patients with head and neck cancers undergo sign...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04901234
Start Date
July 30 2021
End Date
December 1 2026
Last Update
December 12 2023
Active Locations (2)
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1
Austin Health
Melbourne, Australia
2
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2x 3E4