Oropharyngeal Squamous Cell CarcinomaNCT01819480
Efficacy and Safety of TORS for SCCA
A study testing Transoral robotic surgery in people with Oropharyngeal Squamous Cell Carcinoma and Supraglottic Squamous Cell Carcinoma, run by Katherine L Fedder at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Squamous Cell Carcinoma, Supraglottic Squamous Cell Carcinoma
- What is being tested?
- Transoral robotic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female
- Diagnosis of either oropharyngeal or supraglottic squamous cell carcinoma
Who cannot join
- Metastatic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
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
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.
- Being tested
- Transoral robotic surgery
- Keywords
- Surgery, Robotic, Carcinoma, squamous cell of head and neck
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral robotic surgeryProcedure or surgery
Transoral robotic surgery using the daVinci robot to remove primary tumor
| Study group | Role | What they receive |
|---|---|---|
| Transoral robotic surgery | Experimental | Transoral robotic surgery Receives: Procedure: Transoral robotic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Duration of time from date of surgery to date of recurrence or death
Measured: 3 years
Secondary outcomes (1)
Disease specific survival
Duration of time from the date of surgery until death with disease present
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Katherine L Fedder
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Katherine L Fedder, University of Virginia
- Investigators
- Katherine L Fedder, MD, Principal investigator, University of Virginia School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819480
- Sponsor's protocol ID
- 16376
- Other IDs
- 16376
- Status last verified
- Feb 2024
- First submitted
- 22 Mar 2013
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01819480
- Acronym / sponsor ID
- 16376
- Keywords
- Surgery, Robotic, Carcinoma, squamous cell of head and neck
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Katherine L FedderUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transoral robotic surgery | Experimental | Procedure: Transoral robotic surgeryTransoral robotic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult male or female
- Diagnosis of either oropharyngeal or supraglottic squamous cell carcinoma
Key exclusion criteria (1 listed)
- Metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transoral robotic surgeryTransoral robotic surgery using the daVinci robot to remove primary tumor | Procedure or surgery | Transoral robotic surgery |
Primary outcome
Progression-free survival
Time frame: 3 years
Duration of time from date of surgery to date of recurrence or death
1 secondary outcome
Disease specific survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine L Fedder, MD principal investigator
University of Virginia School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transoral robotic surgery in people with Oropharyngeal Squamous Cell Carcinoma and Supraglottic Squamous Cell Carcinoma, run by Katherine L Fedder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.