Actively Recruiting
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2023-12-12
120
Participants Needed
2
Research Sites
104 weeks
Total Duration
C
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
A
Austin Health
Collaborating Sponsor
Researchers are evaluating a new approach to treating patients with squamous cell carcinoma of the oropharynx who have larger primary tumors (stage T3-T4). This phase II randomized trial compares the current standard chemoradiation treatment with a new method that adapts radiotherapy based on MRI scans taken mid-treatment. The goal is to see if adjusting radiation therapy according to tumor shrinkage seen on MRI can reduce swallowing difficulties measured six months after treatment. Participants will be randomly assigned to one of two groups. The standard care group receives radiotherapy planned at the start of treatment, with adjustments only if major anatomical changes occur. The experimental group receives systematic radiation plan changes guided by mid-treatment MRI scans to target the shrinking tumor. Both groups may also receive chemotherapy as part of their treatment. This study uses advanced MR-Linac technology to enable detailed imaging during therapy. During the study, patients will undergo assessments including patient-reported swallowing function measured six months after treatment using the MD Anderson Dysphagia Inventory. Researchers will also monitor acute and late side effects for up to five years after chemoradiation. The trial includes safety monitoring and statistical review of interim data to ensure appropriate sample size. Participation involves regular clinical visits, imaging, and questionnaires to track treatment effects and quality of life.
CONDITIONS
Adaptive RadioTherapy for OroPharynx Cancer
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 7 weeks
Participants receive radiotherapy with or without chemotherapy. One group will have standard radiotherapy without planned adaptation except for major dosimetric deviations, while the other group will have systematic MRI-based radiotherapy adaptation mid-treatment according to tumor changes.
Weekly visits for treatment sessions and assessments
Duration - Up to 5 years post-treatment
Participants are monitored for patient-reported dysphagia and acute and late toxicities up to 5 years after treatment ends.
Visits at 6 months post-treatment and periodic assessments thereafter
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Philippe Giguère, Houda Bahig, Sydney Westra...
https://pubmed.ncbi.nlm.nih.gov/42032732