The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma (SCCA) (SIRS TRIAL)

Inclusion Criteria

• •Patients may be screened and consented if they display clinical features that are consistent with p16 positivity, they are p16+ but and not yet tested for p16 by IHC and for HPV by PCR and if they meet the other eligibility criteria. They will enter the experimental post-surgical portion of the study if they have surgery performed at MSSM and surgical specimens or biopsies proven to be both p16+ on IHC testing and HPV+ on PCR testing
• •Participants must have histologically or cytologically confirmed and identified resectable primary squamous cell carcinoma of the oropharynx that is HPV 16 positive or positive for any high risk HPV subtype (i.e., 18, 33, 35, etc.) as determined by PCR at the central laboratory. Patients must have p16+ status as determined by IHC performed or reviewed at the central laboratory prior to consent. Both p16 and HPV status must be determined prior to post-surgical adjuvant treatment assignment. Tissue from the primary site must be available for biomarker studies after surgery.
• •Stage 1, 2, 3 or early and intermediate stage IVa (T1N0-2B, T2N0-2B) (Level 2, non-matted) disease without evidence distant metastases or extracapsular extension. Primary site must be lateralized for a functional dissection.
• •Age \> 18 years.
• •No previous surgery, radiation therapy or chemotherapy for SCCHN (other than biopsy or tonsillectomy) is allowed at time of study entry.
• •ECOG performance status of 0 or 1.
• •No active alcohol addiction (as assessed by medical caregiver).
• •No active tobacco use (\>10 years tobacco free interval, \<20pk/yr. history)
• •Ability to understand and the willingness to sign a written informed consent document.
• •Participants must have adequate bone marrow, hepatic and renal functions as defined below:
• •1. Hematology:
• •* Neutrophil count \> 1.5 x 109/l.
• •* Platelet count \> 100 x 109/l.
• •* Hemoglobin \> 10 g/dl (may achieve by transfusion).
• •2. Renal function: \> 60 ml/min (actual or calculated by the Cockcroft-Gault method) as follows:
• •* CrCl (mL/min) = (140-age) (weight kg)
• •* 72 x serum creatinine (mg/dL)
• •* N.B. For females, use 85% of calculated CrCl value.
• •* Or a Creatinine \< the upper limits of normal