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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ho-Sheng Lin, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00918762
First received: June 9, 2009
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Perioperative/Postoperative Complications
Precancerous Condition
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
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Assessing the Use of DA VINCI® Robotic Surgical System in Laryngeal and Pharyngeal Surgeries

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Operative time that directly affects operative cost [ Time Frame: post operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood loss [ Time Frame: During surgery ] [ Designated as safety issue: Yes ]
  • Intra-operative and post-operative complications [ Time Frame: during the operation and post operative ] [ Designated as safety issue: Yes ]
  • Need for reconstruction [ Time Frame: post operative ] [ Designated as safety issue: No ]
  • Margins status [ Time Frame: post operative ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: during time as inpatient ] [ Designated as safety issue: No ]
  • Tracheostomy and PEG dependence [ Time Frame: post operative ] [ Designated as safety issue: No ]
  • Days to oral intake [ Time Frame: post operative ] [ Designated as safety issue: No ]
  • Time to locoregional recurrence [ Time Frame: post operative ] [ Designated as safety issue: No ]
  • Speech intelligibility [ Time Frame: post operative ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 3 months and 6 month following completion of surgery ] [ Designated as safety issue: No ]
  • Postoperative pain [ Time Frame: post operative ] [ Designated as safety issue: No ]
  • Proportion of robotic surgical cases where adequate surgical exposure allowed for successful operation completion [ Time Frame: post operative ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: May 2009
Study Completion Date: October 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: daVinci® Robotic Surgical System
Participants will undergo a planned surgical procedures via the robotic approach.
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918762

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Ho-Sheng Lin, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Ho-Sheng Lin, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00918762     History of Changes
Other Study ID Numbers: CDR0000642940, P30CA022453, WSU-2008-022
Study First Received: June 9, 2009
Last Updated: May 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Postoperative Complications
Precancerous Conditions
Neoplasms by Site
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014