This phase II trial studies how well using circulating tumor deoxyribonucleic acid (DNA) to guide lower dose radiation therapy works in treating patients with human papillomavirus infection (HPV)-associated oropharyngeal cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Recently, a blood test has been developed to detect the human papillomavirus in the blood and determine how many viral particles are present. Researchers want to compare any good and bad effects of using the lower dose radiation therapy with chemotherapy compared to the usual standard of care dose chemotherapy in patients who clear the human papillomavirus particles from their blood.
Pathologically confirmed diagnosis of squamous cell carcinoma of the oropharynx (unknown primary, base of tongue, tonsil, oropharyngeal walls, soft palate). Cytologic or fine needle aspiration (FNA) confirmation is sufficient if a biopsy of the primary tumor is not feasible
P16 positive immunohistochemical staining. FNA may be used as the sole diagnostic tissue. If staining was done at an outside hospital, central review by the Ohio State University (OSU) department of pathology must occur prior to trial enrollment
Clinical stage T0, N1-N2, T1-2, N1-N2, T3-T4, N0-2 (American Joint Committee on Cancer [AJCC] 8th edition) including no evidence of distant metastases based on general history, imaging, physical examination, and examination with laryngopharyngoscopy
Clinical or radiographic evidence of measurable disease at the primary site or lymph nodes. Simple tonsillectomy or excision of primary without removal of nodal disease is permitted, as is excision of gross nodes but with intact primary site
Recurrent disease
Clinical or radiographic evidence of metastatic disease or adenopathy below the clavicles
Cancers from an oral cavity site, even if p16 positive
Patients with simultaneous primary cancers or separate bilateral primary tumors will be excluded, except for patients with bilateral tonsil cancers
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Carboplatin
DrugGiven IV
Cisplatin
DrugGiven IV
Computed Tomography
Procedure/SurgeryUndergo PET/CT
External Beam Radiation Therapy
RadiationUndergo external beam radiotherapy
Paclitaxel
DrugGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Questionnaire Administration
Other interventionAncillary studies
Positron emission tomography complete response
Will be evaluated using the Hopkins Criteria which predicts Overall Survival (OS) and Progression-free survival (PFS) in patients with HPV positive oropharyngeal cancers. Separate scores are given for the primary tumor, right neck, and left neck. The activity in the internal jugular vein (IJV) is taken as background blood pool for reference. A score of 1 is consistent with a complete metabolic response, a score of 2 is associated with likely complete metabolic response, a score of 3 is likely inflammatory changes, and a score of 4 is considered likely residual tumor. The overall assessment is denoted by the overall score, which is the highest score among the scores for the primary tumor and right and left neck.
Progression free survival
Will be will be analyzed using Kaplan Meier methods.
Incidence of adverse events
The treating physician will evaluate all adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Any adverse event which changes CTCAE grade over the course of a given episode will have each change of grade recorded in the electronic medical record.
Quality of life (QOL)
Will be measured by the MD Anderson Dysphagia Inventory (MDADI) global QOL score. The MDADI is a 20-item self-administered patient reported dysphagia assessment instrument and incorporates global, functional, emotion, and physical subscales. Two overall scores are obtained which include the global and composite scores. The global score is from a single item and the composite score summarizes the remaining 19 items as a weighted average of the physical, emotional, and functional subscales. The scores range from 0 (extremely low functioning) to 100 (high functioning).
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