Actively Recruiting
Adaptive RadioTherapy for OroPharynx Cancer
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2023-12-12
120
Participants Needed
2
Research Sites
278 weeks
Total Duration
On this page
Sponsors
C
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
A
Austin Health
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Adaptive RadioTherapy for OroPharynx Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �318 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 with or without 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 will not qualify if you...
- Previous irradiation of the head and neck region, excluding superficial radiation therapy for non-melanomatous skin cancer
- Previous surgery of the head and neck region except for biopsies
- Pregnancy or breastfeeding
- Connective tissue disease
- Any medical condition that could prevent follow-up after radiotherapy
- Contraindications to MRI
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Austin Health
Melbourne, Australia
Not Yet Recruiting
2
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2x 3E4
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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