NCT03224000Active, not recruitingPhase 2
Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer
Bayesian Phase II Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
The goal of this clinical research study is to compare the use of MRI simulations to plan different doses of intensity modulated radiotherapy (IMRT) to the standard IMRT dose in patients with low risk human papilloma virus positive oropharyngeal cancer. This is an investigational study. MRI simulations and radiation therapy are delivered using FDA-approved and commercially available methods. The use of MRI imaging to plan the dose is investigational. Up to 90 participants will be enrolled in this study. All will take part at MD Anderson.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 14 Jul 2017
- Start date
- 17 Jan 2018
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Head and neck cancer
- NCT number
- NCT03224000
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 90
- From 17 Jan 2018 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- 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.
Other illness
- Patients who have undergone definitive resection of their primary or nodal disease as well as any chemotherapy or radiation therapy for their HNSCC.
- Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to:
- Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device
- Myocardial infarction within 3 months of registration
- History of claustrophobia
Lab values
- Having an estimated glomerular filtration rate (GFR) \< 40ml/min/1.73m2
Other
- Pregnant or breast-feeding females
- Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators, stimulators, pacemakers, or neurotransmitters) per institutional policy on management of patients with internal and external medical devices.
Who the study is looking for
- Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls). Clinical evidence should be documented, and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient to estimate the size of the primary for purposes of T staging.
- Age ≥18 years
- Clinical stage T1-3, N0-2 (AJCC, 8th ed.), with no distant metastases, based on routine staging workup.
- Positive for HPV by p16 IHC or ISH
- Lifetime pack-year history of \<10 years, currently non-smoking for at least 5 years.
- No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies.
- No retropharyngeal nor level IV (or lower) lymphadenopathy (i.e. nodes in level I-III only)
- Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2.
- Dispositioned to photon/proton radiotherapy +/- chemotherapy
- For females of child-bearing age, a negative pregnancy test
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.