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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
assessment of therapy complications
diagnostic endoscopic surgery
quality-of-life assessment
therapeutic conventional surgery
therapeutic endoscopic surgery
transoral robotic surgery
video-assisted surgery
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

daVinci® Robotic Surgical System

Arm Description

Participants will undergo a planned surgical procedures via the robotic approach.

Outcomes

Primary Outcome Measures

Operative time that directly affects operative cost

Secondary Outcome Measures

Blood loss
Intra-operative and post-operative complications
Need for reconstruction
Margins status
Length of hospital stay
Tracheostomy and PEG dependence
Days to oral intake
Time to locoregional recurrence
Speech intelligibility
Quality of life
Postoperative pain
Proportion of robotic surgical cases where adequate surgical exposure allowed for successful operation completion

Full Information

First Posted
June 9, 2009
Last Updated
May 7, 2014
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00918762
Brief Title
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
daVinci® Robotic Surgical System
Arm Type
Experimental
Arm Description
Participants will undergo a planned surgical procedures via the robotic approach.
Intervention Type
Procedure
Intervention Name(s)
assessment of therapy complications
Intervention Type
Procedure
Intervention Name(s)
diagnostic endoscopic surgery
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Type
Procedure
Intervention Name(s)
therapeutic endoscopic surgery
Intervention Type
Procedure
Intervention Name(s)
transoral robotic surgery
Intervention Type
Procedure
Intervention Name(s)
video-assisted surgery
Primary Outcome Measure Information:
Title
Operative time that directly affects operative cost
Time Frame
post operative
Secondary Outcome Measure Information:
Title
Blood loss
Time Frame
During surgery
Title
Intra-operative and post-operative complications
Time Frame
during the operation and post operative
Title
Need for reconstruction
Time Frame
post operative
Title
Margins status
Time Frame
post operative
Title
Length of hospital stay
Time Frame
during time as inpatient
Title
Tracheostomy and PEG dependence
Time Frame
post operative
Title
Days to oral intake
Time Frame
post operative
Title
Time to locoregional recurrence
Time Frame
post operative
Title
Speech intelligibility
Time Frame
post operative
Title
Quality of life
Time Frame
3 months and 6 month following completion of surgery
Title
Postoperative pain
Time Frame
post operative
Title
Proportion of robotic surgical cases where adequate surgical exposure allowed for successful operation completion
Time Frame
post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho-Sheng Lin, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States

12. IPD Sharing Statement

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

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