Adaptive radiotherapy for oropharynx cancer
Adaptive RadioTherapy for Locally Advanced OroPharynx Cancer (ART-OPC) A Phase II Randomized Trial
This study is testing if adjusting radiation treatment using MRI during therapy can help people with advanced throat cancer swallow better after their treatment compared to standard care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Melbourne and 1 other locations) |
| Trial ID | NCT04901234 on ClinicalTrials.gov |
What this trial studies
This phase II randomized trial aims to evaluate the effectiveness of mid-treatment MRI-based radiotherapy adaptation compared to standard care in patients with squamous cell carcinoma of the oropharynx. The study focuses on patients with T3-T4 tumors undergoing curative chemoradiation. The primary goal is to assess the impact of treatment adaptation on patient-reported dysphagia six months post-treatment. By utilizing MRI technology, the trial seeks to improve treatment outcomes by addressing anatomical changes during the radiotherapy course.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with biopsy-proven squamous cell carcinoma of the oropharynx and T3-T4 tumors planned for curative radiotherapy.
Not a fit: Patients with previous head and neck radiation, certain medical conditions, or contraindications to MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce dysphagia and improve the quality of life for patients undergoing treatment for oropharynx cancer.
How similar studies have performed: While the use of MRI for treatment adaptation is gaining traction, there is currently no established clinical advantage demonstrated in head and neck cancer, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Melbourne and 1 other locations
- Austin Health — Melbourne, Australia (Not_yet_recruiting)
- Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.