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RECRUITINGPhase 2INTERVENTIONAL

Adaptive RadioTherapy for OroPharynx Cancer

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥18 years - Ability to provide written willing to sign a consent form. - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

RADIATION

Standard radiotherapy +/- chemotherapy

No radiotherapy adaptation unless major dosimetric deviation

RADIATION

Experimental radiotherapy +/- chemotherapy

Systemic MRI-based radiotherapy adaptation mid-treatment

Locations (2)

Austin Health
Melbourne, Australia
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada