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New treatment option for Oropharynx Cancer
Official title Adaptive RadioTherapy for OroPharynx Cancer
ClinicalTrials.gov ID: NCT04901234
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Australia
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Australia; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.