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

May 7, 2014 updated by: Ho-Sheng Lin, Barbara Ann Karmanos Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Operative time that directly affects operative cost
Time Frame: post operative
post operative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barbara Ann Karmanos Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Ho-Sheng Lin, MD, Barbara Ann Karmanos Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (Estimate)

June 11, 2009

Study Record Updates

Last Update Posted (Estimate)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000642940
  • P30CA022453 (U.S. NIH Grant/Contract)
  • WSU-2008-022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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