NCT04901234 Adaptive RadioTherapy for OroPharynx Cancer
| NCT ID | NCT04901234 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Oropharynx Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-07-30 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2021-07-30 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Frequently Asked Questions
Who can join the NCT04901234 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oropharynx Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04901234 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04901234 currently recruiting?
Yes, NCT04901234 is actively recruiting participants. Visit ClinicalTrials.gov or contact Centre hospitalier de l'Université de Montréal (CHUM) to inquire about joining.
Where is the NCT04901234 trial being conducted?
This trial is being conducted at Melbourne, Australia, Montreal, Canada.
Who is sponsoring the NCT04901234 clinical trial?
NCT04901234 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The trial plans to enroll 120 participants.
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