Transoral Robotic Surgery in Treating Patients With Benign or Stage I-IV Head and Neck Cancer

PRIMARY OBJECTIVES: To conduct a pilot study at City of Hope (COH) which assesses the
feasibility and safety of TORS (Transoral robotic surgery), including: total operative time,
blood loss, hospitalization time, need to convert to an open procedure, intra-operative as
well as post-operative complications. SECONDARY OBJECTIVES: I. To collect data on oncologic
outcomes, disease free survival, local control rate and overall survival. II. To collect
normative data regarding objective functional outcomes (FO) which may impact quality of life
in patients undergoing TORS, including need for adjunctive procedures, such as gastrostomy
tube placement and tracheostomy placement, and with regards to speech, swallowing function
and pain, using patient-report outcomes instruments. OUTLINE: Patients undergo transoral
robotic microsurgery. After completion of study treatment, patients are followed up
periodically for 5 years.

Inclusion Criteria:

- Patients clinical, radiologic or pathologic evidence of a benign or malignant tumor
in the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, retropharynx or
parapharyngeal space

- Surgical access is amenable to treatment with conventional transoral surgical
procedures

- ASA (American Society of Anesthesiologists) performance status (PS) of 1-4 or ECOG
(Eastern Cooperative Oncology Group) PS 0-3, thereby including a population that
stands to gain the most from a minimally invasive surgical approach

- Patients should have no serious acute infection

- Patients must sign a study-specific informed consent form

Exclusion Criteria:

- Evidence of distant metastases (below the clavicle) by clinical or radiographic
measures

- ASA score > 4; ECOG PS score > 3

- Pregnancy (during first or 3rd trimester - due to risks of anesthesia)

- The presence of medical conditions which contraindicate general anesthesia

- Unexplained fever or untreated, active infection

- Inability to obtain exposure to allow performance of the planned transoral surgical
procedure

- Proposed surgical site with history of prior treatment: radiation

- Tumor adherent to carotid artery or jugular vein

- Fixation to pre-vertebral tumor

- Mandibular invasion