Clinical trial NCT00918762: Transoral Robotic Surgery or Standard Surgery in Treating Patients With Benign or Malignant Tumors of the Larynx and Pharynx
Official title: A Pilot Study Assessing the Use of DA VINCI® Robotic Surgical System in Laryngeal and Pharyngeal Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head and Neck Cancer
Perioperative/Postoperative Complications
Precancerous Condition
Keywords: 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
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-06-11
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Operative time that directly affects operative cost
timeFrame: post operative
Secondary outcomes:
measure: Blood loss
timeFrame: During surgery
measure: Intra-operative and post-operative complications
timeFrame: during the operation and post operative
measure: Need for reconstruction
timeFrame: post operative
measure: Margins status
timeFrame: post operative
measure: Length of hospital stay
timeFrame: during time as inpatient
measure: Tracheostomy and PEG dependence
timeFrame: post operative
measure: Days to oral intake
timeFrame: post operative
measure: Time to locoregional recurrence
timeFrame: post operative
measure: Speech intelligibility
timeFrame: post operative
measure: Quality of life
timeFrame: 3 months and 6 month following completion of surgery
measure: Postoperative pain
timeFrame: post operative
measure: Proportion of robotic surgical cases where adequate surgical exposure allowed for successful operation completion
timeFrame: post operative
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Ho-Sheng Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: