Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer

Running, not enrolling · Phase 2

Conditions studied: Malignant Neoplasms of Lip Oral Cavity and Pharynx, Oropharyngeal Cancer

In brief

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.

Key facts

Study ID

NCT03224000

Run by

M.D. Anderson Cancer Center

People needed

90

Starts

2018-01-17

Expected to finish

2026-12-31

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients who have undergone definitive resection of their primary or nodal disease as well as any chemotherapy or radiation therapy for their HNSCC.
• Pregnant or breast-feeding females
• 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
• 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.
• History of claustrophobia
• Having an estimated glomerular filtration rate (GFR) < 40ml/min/1.73m2

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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