NCT01819480

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

11.8 years

First QC Date

March 22, 2013

Last Update Submit

February 7, 2024

Conditions

Oropharyngeal Squamous Cell CarcinomaSupraglottic Squamous Cell Carcinoma

Keywords

SurgeryRoboticCarcinomasquamous cell of head and neck

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    Duration of time from date of surgery to date of recurrence or death

    3 years

Secondary Outcomes (1)

  • Disease specific survival

    3 years

Other Outcomes (3)

  • Overall survival

    3 years

  • Functional quality of life

    3 years

  • Incidence of adverse events

    3 years

Study Arms (1)

Transoral robotic surgery

EXPERIMENTAL

Transoral robotic surgery

Procedure: Transoral robotic surgery

Interventions

Transoral robotic surgeryPROCEDURE

Transoral robotic surgery using the daVinci robot to remove primary tumor

Transoral robotic surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Metastatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckCarcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Katherine L Fedder, MD

    University of Virginia School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2013

First Posted

March 27, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

February 9, 2024

Record last verified: 2024-02

Locations

US(1)