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

City of Hope Medical Center7 enrolled

Overview

RATIONALE: Transoral robotic surgery (TORS) is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies how transoral robotic surgery works 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Recurrent Adenoid Cystic Carcinoma of the Oral Cavity

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Assessment of the feasibility of Transoral Robotic Surgery (TORS) in improving transoral accessibility within the upper aerodigestive tract in patients with benign or malignant head and neck tumors