Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer
Malignant Neoplasms of Lip Oral Cavity and Pharynx, Oropharyngeal Cancer
About this trial
This is an interventional treatment trial for Malignant Neoplasms of Lip Oral Cavity and Pharynx focused on measuring Malignant neoplasms of lip oral cavity and pharynx, Oropharyngeal Cancer, Human papilloma virus positive, HPV+, Squamous cell carcinoma of the oropharynx, Squamous cell carcinoma of the tonsil, Squamous cell carcinoma of the base of tongue, Squamous cell carcinoma of the soft palate, Squamous cell carcinoma of the oropharyngeal walls, Magnetic Resonance Imaging Guided Radiotherapy, Standard of Care Radiotherapy Planning, Radiation Therapy, Intensity modulated radiotherapy, IMRT, Modified Barium Swallow, MBS, Swallowing questionnaire, The M.D. Anderson Dysphagia Inventory (MDADI), Symptom questionnaire, The M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN), Video-Strobe Procedure
Eligibility Criteria
Inclusion Criteria:
- 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 T1-2, N0-1, or small volume N2b (AJCC, 7th ed.), with no distant metastases, based on routine staging workup.
- Positive for HPV by p16 immunohistochemistry (IHC) or in situ hybridization (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 lymph nodes larger than 3 cm in the greatest dimension
- 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 single modality photon radiotherapy (i.e. no chemotherapy or previous therapeutic intent surgery).
- For females of child-bearing age, a negative pregnancy test
Exclusion Criteria:
- Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)
- 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/1.73m^2
Sites / Locations
- University of Texas MD Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
MRI Guided Intensity Modulated Radiotherapy (IMRT)
Standard-of-Care Intensity Modulated Radiotherapy (IMRT)
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy. Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. IMRT planned with MRI guidance. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy. Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. IMRT planned by standard-of-care. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.