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NCT01819480 Clinical Trial

Efficacy and Safety of TORS for SCCA

Oropharyngeal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01819480
Other study ID # 16376
Secondary ID 16376
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 2013
Est. completion date December 2025

Study information
Verified date February 2024
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 110
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult male or female - Diagnosis of either oropharyngeal or supraglottic squamous cell carcinoma Exclusion Criteria: - Metastatic disease

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Transoral robotic surgery
Transoral robotic surgery using the daVinci robot to remove primary tumor

Locations
Country Name City State
United States University of Virginia Health System Charlottesville Virginia

Sponsors (1)
Lead Sponsor Collaborator
Katherine L Fedder

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Overall survival Measured from the date of surgery until date of death from any cause 3 years
Other Functional quality of life Subject-reported functional outcome questionnaires will be used to quantify patient-reported speech and swallowing function 3 years
Other Incidence of adverse events Adverse events occuring following the surgery will be reported and graded using CTCAE v4.0 criteria 3 years
Primary Progression-free survival Duration of time from date of surgery to date of recurrence or death 3 years
Secondary Disease specific survival Duration of time from the date of surgery until death with disease present 3 years
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