ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx

Eligibility Criteria

• * Subjects ≥ 18 years old at the time of informed consent.
• * Ability to provide written informed consent and HIPAA authorization.
• * Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• * Primary tumor of the oropharynx (palatine tonsil, tongue base, soft palate, lateral or posterior walls of oropharynx).
• * Histopathologically confirmed squamous cell carcinoma.
• * Detectable ctHPVDNA from blood samples collected prior to treatment.
• * Resectable and accessible tumor with high probability of achieving negative margins.
• * Smokers and non-smokers included.
• * Tumor stage (AJCC 8th edition): T1 or T2, and select T3 tumors that are mobile and do not invade the larynx.
• * Nodal stage (AJCC 8th edition): N0, N1 or N2.
• * Mobile neck nodes on physical exam if N positive.
• * HPV+ tumor, as determined by p16, in-situ hybridization, real-time polymerase chain reaction, or ctHPVDNA.
• * Serious medical condition preventing general anesthesia for surgery.
• * History of previous head and neck radiation or previous head and neck cancer within 3 years.
• * Distant metastatic disease present.
• * Subjects with synchronous HPV+ oropharynx primaries
• * Prior invasive malignant disease within 3 years, with the exception of non-melanoma skin cancer and thyroid cancer, unless patient is deemed cured or disease free, in which case patient may be included in the study.
• * Lactating or pregnant women. Women of childbearing potential must have a negative pregnancy test on the day of surgery. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:
• 1. Has undergone a hysterectomy or bilateral oophorectomy; or
• 2. Has been naturally amenorrheic for at least 12 consecutive months.