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

Not Applicable

Terminated

• Conditions: Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Oropharynx; Stage I Lymphoepithelioma of the Nasopharynx; Stage I Lymphoepithelioma of the Oropharynx; Recurrent Lymphoepithelioma of the Oropharynx; Recurrent Mucoepidermoid Carcinoma of the Oral Cavity; Stage I Mucoepidermoid Carcinoma of the Oral Cavity; Stage I Squamous Cell Carcinoma of the Larynx; Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage I Squamous Cell Carcinoma of the Oropharynx
• Interventions: Procedure: transoral robotic surgery; Other: laboratory biomarker analysis; Procedure: quality-of-life assessment

• Registration Number: NCT01254734
• Lead Sponsor: City of Hope Medical Center

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 Description

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 Timeline

• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-07
• Study Start: 2011-04
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-07
• Last Update Posted: 2014-11-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	transoral robotic surgery	Patients undergo transoral robotic microsurgery.
Arm I	laboratory biomarker analysis	Patients undergo transoral robotic microsurgery.
Arm I	quality-of-life assessment	Patients undergo transoral robotic microsurgery.

Primary Outcome Measures

Name	Time	Method
Assessment of blood loss during transoral surgery using TORS in patients with benign or malignant head and neck tumors	From 6 months to 3 years after completion of study treatment
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	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	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	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	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	From 6 months to 3 years after completion of study treatment

Secondary Outcome Measures

Name	Time	Method
Collection of data on oncologic outcomes, disease free survival, local control rate and overall survival.	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	From 6 months to 3 years after completion of study treatment

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States