Back to resultsEfficacy and Safety of TORS for SCCA
Primary Purpose
Oropharyngeal Squamous Cell Carcinoma, Supraglottic Squamous Cell Carcinoma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transoral robotic surgery
Sponsored by
About this trial
This is an interventional treatment trial for Oropharyngeal Squamous Cell Carcinoma focused on measuring Surgery, Robotic, Carcinoma, squamous cell of head and neck
Eligibility Criteria
Inclusion Criteria:
- Adult male or female
- Diagnosis of either oropharyngeal or supraglottic squamous cell carcinoma
Exclusion Criteria:
- Metastatic disease
Sites / Locations
- University of Virginia Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transoral robotic surgery
Arm Description
Transoral robotic surgery
Outcomes
Primary Outcome Measures
Progression-free survival
Duration of time from date of surgery to date of recurrence or death
Secondary Outcome Measures
Disease specific survival
Duration of time from the date of surgery until death with disease present
Full Information
NCT ID
NCT01819480
First Posted
March 22, 2013
Last Updated
November 20, 2022
Sponsor
Mark J Jameson, MD, PhD
1. Study Identification
Unique Protocol Identification Number
NCT01819480
Brief Title
Efficacy and Safety of TORS for SCCA
Official Title
A Single Arm Study of Efficacy and Functional Quality of Life in Patients Treated With Transoral Robotic Surgery for Oropharyngeal and Supraglottic Squamous Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark J Jameson, MD, PhD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to learn more about the outcomes of treatment of throat and voice box cancers using transoral robotic surgery (TORS). TORS is a relatively new option involving the use of the da Vinci surgical robot to remove these cancers through the mouth.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Squamous Cell Carcinoma, Supraglottic Squamous Cell Carcinoma
Keywords
Surgery, Robotic, Carcinoma, squamous cell of head and neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transoral robotic surgery
Arm Type
Experimental
Arm Description
Transoral robotic surgery
Intervention Type
Procedure
Intervention Name(s)
Transoral robotic surgery
Intervention Description
Transoral robotic surgery using the daVinci robot to remove primary tumor
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Duration of time from date of surgery to date of recurrence or death
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Disease specific survival
Description
Duration of time from the date of surgery until death with disease present
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Overall survival
Description
Measured from the date of surgery until date of death from any cause
Time Frame
3 years
Title
Functional quality of life
Description
Subject-reported functional outcome questionnaires will be used to quantify patient-reported speech and swallowing function
Time Frame
3 years
Title
Incidence of adverse events
Description
Adverse events occuring following the surgery will be reported and graded using CTCAE v4.0 criteria
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult male or female
Diagnosis of either oropharyngeal or supraglottic squamous cell carcinoma
Exclusion Criteria:
Metastatic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Jameson, MD, PhD
Organizational Affiliation
University of Virginia School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of TORS for SCCA
We'll reach out to this number within 24 hrs