Transoral Robotic Surgery or Standard Surgery in Treating Patients With Benign or Malignant Tumors of the Larynx and Pharynx
NCT ID: NCT00918762
Last Updated: 2014-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2009-05-31
2010-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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daVinci® Robotic Surgical System
Participants will undergo a planned surgical procedures via the robotic approach.
assessment of therapy complications
diagnostic endoscopic surgery
quality-of-life assessment
therapeutic conventional surgery
therapeutic endoscopic surgery
transoral robotic surgery
video-assisted surgery
Interventions
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assessment of therapy complications
diagnostic endoscopic surgery
quality-of-life assessment
therapeutic conventional surgery
therapeutic endoscopic surgery
transoral robotic surgery
video-assisted surgery
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Barbara Ann Karmanos Cancer Institute
OTHER
Responsible Party
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Ho-Sheng Lin
Principal Investigator
Principal Investigators
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Ho-Sheng Lin, MD
Role: PRINCIPAL_INVESTIGATOR
Barbara Ann Karmanos Cancer Institute
Locations
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Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Countries
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Other Identifiers
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WSU-2008-022
Identifier Type: -
Identifier Source: secondary_id
CDR0000642940
Identifier Type: -
Identifier Source: org_study_id
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