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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Outcomes in Transoral Robotic Microsurgery for Head and Neck Tumors

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: City of Hope Medical Center

Current Primary Outcome:

  • 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 [ Time Frame: From 6 months to 3 years after completion of study treatment ]
  • Assessment of the total operative time to perform transoral surgery using TORS in patients with benign or malignant head and neck tumors [ Time Frame: From 6 months to 3 years after completion of study treatment ]
  • Assessment of blood loss during transoral surgery using TORS in patients with benign or malignant head and neck tumors [ Time Frame: From 6 months to 3 years after completion of study treatment ]
  • Assessment of hospitalization time of in patients with benign or malignant head and neck tumors undergoing transoral surgery using TORS [ Time Frame: From 6 months to 3 years after completion of study treatment ]
  • Assessment of the need to convert to an open procedure during transoral surgery using TORS in patients with benign or malignant head and neck tumors [ Time Frame: From 6 months to 3 years after completion of study treatment ]
  • Assessment of complications of transoral surgery using TORS in patients with benign or malignant head and neck tumors [ Time Frame: From 6 months to 3 years after completion of study treatment ]


Original Primary Outcome:

  • 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 [ Time Frame: From 6 months to 3 years after completion of study treatment ]
  • Assessment of the efficacy of TORS in patients with malignancies by studying oncologic outcomes in these patients as compared to data available in a comparable cancer population [ Time Frame: From 6 months to 3 years after completion of study treatment ]
  • Assessment of quality of life outcomes in patients undergoing TORS using patient-report outcomes instruments [ Time Frame: From 6 months to 3 years after completion of study treatment ]


Current Secondary Outcome:

  • Collection of data on oncologic outcomes, disease free survival, local control rate and overall survival. [ Time Frame: From 6 months to 3 years after completion of study treatment ]
  • Assessment of quality of life outcomes in patients undergoing TORS using patient-report outcomes instruments [ Time Frame: From 6 months to 3 years after completion of study treatment ]


Original Secondary Outcome:

  • Assessment of the total operative time to perform transoral surgery using TORS in patients with benign or malignant head and neck tumors [ Time Frame: From 6 months to 3 years after completion of study treatment ]
  • Assessment of blood loss during transoral surgery using TORS in patients with benign or malignant head and neck tumors [ Time Frame: From 6 months to 3 years after completion of study treatment ]
  • Assessment of hospitalization time of in patients with benign or malignant head and neck tumors undergoing transoral surgery using TORS [ Time Frame: From 6 months to 3 years after completion of study treatment ]
  • Assessment of the need to convert to an open procedure during transoral surgery using TORS in patients with benign or malignant head and neck tumors [ Time Frame: From 6 months to 3 years after completion of study treatment ]
  • Assessment of complications of transoral surgery using TORS in patients with benign or malignant head and neck tumors [ Time Frame: From 6 months to 3 years after completion of study treatment ]


Information By: City of Hope Medical Center

Dates:
Date Received: November 3, 2010
Date Started: April 2011
Date Completion:
Last Updated: November 7, 2014
Last Verified: November 2014