RecruitingPhase 2NCT04901234

Adaptive RadioTherapy for OroPharynx Cancer

Adaptive RadioTherapy for Locally Advanced OroPharynx Cancer (ART-OPC) A Phase II Randomized Trial

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrollment

120 participants

Start Date

Jul 30, 2021

Study Type

INTERVENTIONAL

Conditions

Radiotherapy Side Effect MRI Radiotherapy; Complications Oropharynx Cancer Dysphagia

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 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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether adapting the radiation treatment plan during therapy — based on how the tumor responds — improves outcomes and reduces side effects for people with advanced throat (oropharyngeal) cancer. **You may be eligible if...** - You are 18 or older and have been diagnosed with squamous cell carcinoma of the oropharynx (throat cancer) - Your cancer is stage T3 or T4 - You are planned to receive radiation therapy, with or without chemotherapy, with a goal of cure - You can have an MRI scan - Women of childbearing age must have a negative pregnancy test **You may NOT be eligible if...** - You have had previous radiation to the head or neck - You have had prior surgery on the head or neck (other than biopsy) - You are pregnant or breastfeeding - You have a connective tissue disorder - You have a medical condition that prevents you from tolerating MRI or completing follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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