NCT04901234RecruitingPhase 2
Adaptive RadioTherapy for OroPharynx Cancer
Adaptive RadioTherapy for Locally Advanced OroPharynx Cancer (ART-OPC) A Phase II Randomized Trial
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 17 May 2021
- Start date
- 30 Jul 2021
- Primary completion date
- Dec 2026
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Diseases
- Head and neck cancer
- NCT number
- NCT04901234
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 30 Jul 2021 to the primary completion date, Dec 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Connective tissue disease
- Any medical condition that could, in the opinion of the investigator, prevent follow-up after radiotherapy.
Other
- Pregnancy or breastfeeding
- Patients with contra-indications to MRI will be excluded.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Austin Health Coordinator of this site? Confirm its status | Melbourne | Australia | Not yet recruiting |
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.