We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of TORS for SCCA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01819480
Recruitment Status : Active, not recruiting
First Posted : March 27, 2013
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Mark J Jameson, MD, PhD, University of Virginia

Tracking Information
First Submitted Date  ICMJE March 22, 2013
First Posted Date  ICMJE March 27, 2013
Last Update Posted Date September 28, 2021
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2013)
Progression-free survival [ Time Frame: 3 years ]
Duration of time from date of surgery to date of recurrence or death
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2013)
Disease specific survival [ Time Frame: 3 years ]
Duration of time from the date of surgery until death with disease present
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 9, 2013)
  • Overall survival [ Time Frame: 3 years ]
    Measured from the date of surgery until date of death from any cause
  • Functional quality of life [ Time Frame: 3 years ]
    Subject-reported functional outcome questionnaires will be used to quantify patient-reported speech and swallowing function
  • Incidence of adverse events [ Time Frame: 3 years ]
    Adverse events occuring following the surgery will be reported and graded using CTCAE v4.0 criteria
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of TORS for SCCA
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Oropharyngeal Squamous Cell Carcinoma
  • Supraglottic Squamous Cell Carcinoma
Intervention  ICMJE Procedure: Transoral robotic surgery
Transoral robotic surgery using the daVinci robot to remove primary tumor
Study Arms  ICMJE Experimental: Transoral robotic surgery
Transoral robotic surgery
Intervention: Procedure: Transoral robotic surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2019)
110
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2013)
85
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult male or female
  • Diagnosis of either oropharyngeal or supraglottic squamous cell carcinoma

Exclusion Criteria:

  • Metastatic disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01819480
Other Study ID Numbers  ICMJE 16376
16376 ( Other Identifier: University of Virginia IRB-HSR )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mark J Jameson, MD, PhD, University of Virginia
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mark J Jameson, MD, PhD
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark J Jameson, MD, PhD University of Virginia School of Medicine
PRS Account University of Virginia
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP