The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)

Exclusion Criteria

• •Age \< 18 years at screening
• •Pregnant or breast-feeding women.
• •Previous or current malignancies at other sites, except for adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, prostate cancer treated with surgery/radiotherapy, ductal carcinoma in situ of the breast treated with surgery/radiotherapy, or other cancer curatively treated and with no current evidence of disease for at least 3 years.
• •Other serious illnesses or medical conditions including but not limited to:
• •* Unstable cardiac disease despite treatment or myocardial infarction within 6 months prior to study entry.
• •* History of significant neurologic or psychiatric disorders including severe dementia or poorly controlled seizures
• •* Active clinically significant uncontrolled infection
• •* Active peptic ulcer disease defined as unhealed or clinically active
• •* Active drug addiction including alcohol, cocaine or intravenous drug use defined as occurring within the 6 months preceding diagnosis
• •* Severe chronic obstructive pulmonary disease, defined as being associated with a hospitalization for pneumonia within 12 months of diagnosis.
• •* Prior organ transplant
• •* Interstitial lung disease
• •* Concurrent treatment with any other anti-cancer therapy
• •* Participation in an investigational therapeutic drug trial within 30 days of study entry. Participation in additional investigational radiation studies will exclude participation in SIRS. Participation in non-therapeutic, non-oncologic investigational studies (i.e. pain control studies, nutritional studies, etc.) will be allowed amongst SIRS participants, provided there is no alteration of treatment planning, oncologic therapy, or surveillance, and additional studies comply with SIRS safety criteria and stopping rules as outlined in the SIRS protocol.
• •* Active hepatitis C by history
• •Advanced nodal stage (AJCC 7th edition N2C, N3) or surgically unresectable disease or disease that cannot be fully resected, unequivocal radiographic extranodal extension, unequivocal radiographic or clinical supraclavicular or matted metastatic disease, \> 3 unequivocally radiographic pathologic cervical nodes.
• •Non-HR-HPV subtype on initial biopsy or final pathology.
• •5 or more positive nodes, irrespective of size, on final pathology.
• •p16 or HPV negative OPSCC as determined by IHC and PCR or ISH, respectively.
• •Undetectable or \< 10 fragments/mL baseline cfHPVDNA prior to surgery.
• •Autoimmune disease treated with chemotherapy agents or anti TNF agents within the last 2 years.
• •Detectable repeat cfHPVDNA 1-5 weeks postoperatively via the NavDX assay, defined as \> 5 fragments/mL.