Efficacy and Safety of TORS for SCCA

February 7, 2024 updated by: Katherine L Fedder

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Metastatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 3 years
Duration of time from date of surgery to date of recurrence or death
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease specific survival
Time Frame: 3 years
Duration of time from the date of surgery until death with disease present
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years
Measured from the date of surgery until date of death from any cause
3 years
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 years
Incidence of adverse events
Time Frame: 3 years
Adverse events occuring following the surgery will be reported and graded using CTCAE v4.0 criteria
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Katherine L Fedder

Investigators

  • Principal Investigator: Katherine L Fedder, MD, University of Virginia School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 22, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (Estimated)

March 27, 2013

Study Record Updates

Last Update Posted (Actual)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16376 (Other Identifier: University of Virginia IRB-HSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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