A Phase 2 interventional study of Standard radiotherapy +/- chemotherapy and Experimental radiotherapy +/- chemotherapy in Oropharynx Cancer, Radiotherapy; Complications and Radiotherapy Side Effect, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Phase 2, Interventional, and Treatment
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.
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 significant anatomical changes, including weight loss and tumor shrinkage (with complete response at mid-treatment in as high as 50% of patients). The current standard of care is to maintain the same radiotherapy plan for the entire treatment duration, unless major dosimetric deviations are detected. The use of MRI for treatment adaptation has the advantage of increased soft tissue contrast and is being integrated into several clinical practises with the recent development of MR-Linac technology. However, there is currently no demonstrated clinical advantage from the use of MRI for treatment adaptation in head and neck cancer.
Primary objective: 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.
Methods: 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. Patients with contra-indications to MRI will be excluded. The study will use a 2-sided, independent-sample t-test with an alpha level of 0.05 and power of 80%, with a 1:1 randomization between the 2 arms. In order to detect a 10-point improvement in the MD Anderson Dysphagia Index (MDADI) and assuming that the quality of life scores would be normally distributed with a standard deviation of 18, a total of 104 patients will be required (52 in each arm), which has been increased to 120 patients overall (60 patients in each arm) to account for a 10% dropout rate in completion of the quality of life scoring at 6 months post-treatment. An independent DSMB will review the pooled standard deviation of the interim data collected for this trial after 40 patients overall have been recruited (20 in each arm) the value of the standard deviation used to calculate the sample size required. The DSMB will inform the study team if there is potential to reduce the sample size if the standard deviation was much lower than 18 (i.e. \<=15 would result in a reduction of 25% in patients required), which will potential reduce the length of the trial. Patients will be stratified by institution and recruited in blocks of 4 to ensure a balance between arms at the interim assessment.
373 studies on the registry are indexed under Oropharyngeal Neoplasms; 97 are open to participants now.
This study's planned enrollment of 120 is above the median of 48 across 284 interventional studies indexed under Oropharyngeal Neoplasms.
Browse Oropharyngeal Neoplasms studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Radiotherapy as planned at baseline, with replanning allowed only if significant weight loss or change in anatomy due to unforeseen circumstances (eg that would affect dosimetry and treatment delivery of baseline treatment plan). No adaptation to shrinking tumour is allowed.
Radiation: Standard radiotherapy +/- chemotherapy
Systematic radiation treatment plan adaptation according to the shrinking tumour on mid-treatment MRI.
Radiation: Experimental radiotherapy +/- chemotherapy
No radiotherapy adaptation unless major dosimetric deviation
Systemic MRI-based radiotherapy adaptation mid-treatment
Patient-reported dysphagia
Patient-reported dysphagia as measured by the MD Anderson Dysphagia Index. Overall score ranges from 0 to 100, with higher score representing better functioning and quality of life.
Time frame: at 6 months post treatment
Acute and late toxicities
Rate of grade ≥ 3 late toxicity as per CTCAE v5.0
Time frame: From treatment start to 5-years after the end of chemoradiation]
Locoregional control
Time frame: at 6 months, 2 and 5 years
Disease-free survival
Time frame: at 6 months, 2 and 5 years
Overall survival
Time frame: at 6 months, 2 and 5 years
Complete response rate
Time frame: at 6 months
Patient-reported dysphagia
Patient-reported dysphagia as measured by the MD Anderson Dysphagia Index. Overall score ranges from 0 to 100, with higher score representing better functioning and quality of life.
Time frame: [Time Frame: At baseline, and 1-, 3-, 12- months post-treatment, and yearly up to 5 years after the end of chemoradiation]
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Centre hospitalier de l'Université de Montréal (CHUM)