Transoral Robotic Surgery or Standard Surgery in Treating Patients With Benign or Malignant Tumors of the Larynx and Pharynx

Study Overview
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Brief Summary
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RATIONALE: Transoral robotic surgery may make it easier to find and remove benign or malignant tumors of the larynx and pharynx and cause less damage to normal tissue. It is not yet known whether transoral robotic surgery is more effective than standard surgery in diagnosing and treating larynx and pharynx tumors. PURPOSE: This phase I trial is studying how well transoral robotic surgery works compared with standard surgery in treating patients with benign or malignant tumors of the larynx or pharynx.

Detailed Description
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OBJECTIVES: Primary Evaluate the potential benefits of using the transoral robotic surgical approach against the conventional open and transoral approaches in patients with benign or malignant disease involving the larynx and pharynx. Secondary Determine the proportion of laryngeal and pharyngeal surgical procedures where the surgical exposure is adequate to allow the successful completion of the surgical resection using the transoral robotic surgical approach. OUTLINE: Patients are assigned to transoral robotic surgery or standard therapy consisting of conventional transoral endoscopic or open approach according to their preference. Patients undergo planned surgical procedures (either diagnostic or therapeutic) appropriate for their disease in the larynx or pharynx via the transoral robotic surgical approach or the conventional transoral endoscopic or open approach. Patients complete the Functional Assessment of Cancer Therapy Head and Neck Scale, the Performance Status Scale for Head and Neck Cancer Patients, and the University of Washington Quality of Life Scale at baseline and at 3 and 6 months. Patients also undergo voice analysis by acoustic analyses, and speech and swallow pathology evaluation by videostroboscopy and modified barium swallow. After completion of study procedure, patients are followed at 3 and 6 months. PROJECTED ACCRUAL: A total of 80 patients will be accrued to the control group (standard conventional surgery) and 30 patients will be accrued to the robotic surgery group.

Official Title
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A Pilot Study Assessing the Use of DA VINCI® Robotic Surgical System in Laryngeal and Pharyngeal Surgeries

Conditions
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Head and Neck Cancer, Perioperative/Postoperative Complications, Precancerous Condition

Intervention / Treatment
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* Procedure: assessment of therapy complications
* Procedure: diagnostic endoscopic surgery
* Procedure: quality-of-life assessment
* Procedure: therapeutic conventional surgery
* Procedure: therapeutic endoscopic surgery
* Procedure: transoral robotic surgery
* Procedure: video-assisted surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Benign or malignant disease of the larynx or pharynx that requires surgical intervention for either diagnostic or therapeutic purposes Malignant disease must meet the following criteria: Histologically confirmed diagnosis of 1 of the following: Glottic cancer (T1, T2, and T3) Supraglottic cancer (T1, T2, and T3) Hypopharyngeal cancer (T1 and T2) Oropharyngeal cancer (T1, T2, and T3) Nasopharyngeal cancer (T1 and T2) Resectable involved lymph nodes No invasion of osseous and/or osseocartilaginous structures including the following: Mandibular bone Thyroid cartilage Hyoid bone Cricoid bone Vertebral body No pharyngeal wall or tongue-based involvement requiring resection of > 50% of the posterior pharyngeal wall or tongue base No radiological confirmation of carotid artery involvement No fixation of tumor to the prevertebral fascia No bilateral arytenoid involvement No surgical defect requiring open approach for reconstruction No evidence of distant metastasis PATIENT CHARACTERISTICS: Not pregnant No unexplained fever and/or untreated active infection No medical conditions contraindicating general anesthesia No inadequate jaw opening due to prior head and neck surgery, trauma, or radiotherapy PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: daVinci® Robotic Surgical System<br>Participants will undergo a planned surgical procedures via the robotic approach. | Procedure: assessment of therapy complications<br> <br> Procedure: diagnostic endoscopic surgery<br> <br> Procedure: quality-of-life assessment<br> <br> Procedure: therapeutic conventional surgery<br> <br> Procedure: therapeutic endoscopic surgery<br> <br> Procedure: transoral robotic surgery<br> <br> Procedure: video-assisted surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time that directly affects operative cost |  | post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss |  | During surgery | 
| Intra-operative and post-operative complications |  | during the operation and post operative | 
| Need for reconstruction |  | post operative | 
| Margins status |  | post operative | 
| Length of hospital stay |  | during time as inpatient | 
| Tracheostomy and PEG dependence |  | post operative | 
| Days to oral intake |  | post operative | 
| Time to locoregional recurrence |  | post operative | 
| Speech intelligibility |  | post operative | 
| Quality of life |  | 3 months and 6 month following completion of surgery | 
| Postoperative pain |  | post operative | 
| Proportion of robotic surgical cases where adequate surgical exposure allowed for successful operation completion |  | post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perioperative/postoperative complications, precancerous condition, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage II verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage I lymphoepithelioma of the nasopharynx, stage I squamous cell carcinoma of the nasopharynx, stage II lymphoepithelioma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage I lymphoepithelioma of the oropharynx, stage I squamous cell carcinoma of the oropharynx, stage II lymphoepithelioma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the oropharynx