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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01819480
Recruitment Status : Recruiting
First Posted : March 27, 2013
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Mark J Jameson, MD, PhD, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Oropharyngeal Squamous Cell Carcinoma Supraglottic Squamous Cell Carcinoma Procedure: Transoral robotic surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2013
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Transoral robotic surgery
Transoral robotic surgery
Procedure: Transoral robotic surgery
Transoral robotic surgery using the daVinci robot to remove primary tumor




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 3 years ]
    Duration of time from date of surgery to date of recurrence or death


Secondary Outcome Measures :
  1. Disease specific survival [ Time Frame: 3 years ]
    Duration of time from the date of surgery until death with disease present


Other Outcome Measures:
  1. Overall survival [ Time Frame: 3 years ]
    Measured from the date of surgery until date of death from any cause

  2. Functional quality of life [ Time Frame: 3 years ]
    Subject-reported functional outcome questionnaires will be used to quantify patient-reported speech and swallowing function

  3. Incidence of adverse events [ Time Frame: 3 years ]
    Adverse events occuring following the surgery will be reported and graded using CTCAE v4.0 criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Metastatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819480


Contacts
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Contact: Bette Ghamandi 434-243-1558 bjf8j@hscmail.mcc.virginia.edu

Locations
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United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Principal Investigator: Mark J Jameson, MD, PhD         
Sponsors and Collaborators
Mark J Jameson, MD, PhD
Investigators
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Principal Investigator: Mark J Jameson, MD, PhD University of Virginia School of Medicine

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Responsible Party: Mark J Jameson, MD, PhD, Assistant Professor, Department of Otolaryngology, University of Virginia
ClinicalTrials.gov Identifier: NCT01819480    
Other Study ID Numbers: 16376
16376 ( Other Identifier: University of Virginia IRB-HSR )
First Posted: March 27, 2013    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Keywords provided by Mark J Jameson, MD, PhD, University of Virginia:
Surgery
Robotic
Carcinoma
squamous cell of head and neck
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell