Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Transoral Robotic Surgery in Treating Patients with Benign or Malignant Tumors of the Head and Neck

Protocol: OSU-07061

Full Title

A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System.

Purpose

This pilot clinical trial studies transoral robotic surgery (TORS) in treating patients with benign or malignant tumors of the head and neck. TORS is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery.

Study Objective

PRIMARY OBJECTIVES:

I. To determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions and non-surgical patients.

SECONDARY OBJECTIVES:

I. To assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications. If the planned procedure is a combined procedure, (robotic + non robotic) above mentioned measures are going to be presented separately for successful fully robotic surgeries and for unsuccessful mixed surgeries.

II. To identify the learning curve for TORS by measuring the efficiency and accuracy of the surgeons who perform the procedures.

III. To assess the quality of life (QOL) of the patients with TORS.

IV. To assess the QOL of the patients with regard to swallowing for those with TORS and without surgery.

OUTLINE:

Patients undergo TORS using the Da Vinci Robotic Surgical System.

After completion of study treatment, patients are followed up at 3 weeks, 3 and 6 months, and then 1 year.

Are you eligible?

Inclusion Criteria:

Patient must present with indications for diagnostic or therapeutic approaches for benign and/or malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)

Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation; for the non-surgical arm: Patients planned to receive non-surgical treatment (e.g., chemo and/or radiation); the 7 surgical (TORS) arms include: tonsil cancer: T1, tonsil cancer: T2, base of tongue cancer: T1, base of tongue cancer: T2, supraglottic cancer, unknown primary cancer, and other tumors; the 3 non-surgical arms are: tonsil cancer, base of tongue cancer, and supraglottic/hypopharyngeal/other cancers

Written informed consent and/or Consent waiver by institutional review board (IRB)

Exclusion Criteria:

Unexplained fever and/or untreated, active infection

Patient pregnancy

Previous head and neck surgery that would preclude transoral/robotic procedures; this is at the investigator’s discretion; this is not an exclusion criterion for the non-surgical arm

The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches; this is not an exclusion criterion for the non-surgical arm

Inability to grant informed consent

INTRAOPERATIVE EXCLUSION CRITERIA:

Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally