Efficacy and Safety of TORS for SCCA | NCT01819480

Studies
Efficacy and Safety of TORS for SCCA

NCT01819480

Sponsor

Katherine L Fedder

Status

Unknown status

Last Update Posted

Feb 9, 2024Actual

Enrollment

110Estimated

Phase

Not Applicable

Conditions

Oropharyngeal Squamous Cell Carcinoma
Supraglottic Squamous Cell Carcinoma

Interventions

Transoral robotic surgery

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
16376	Other Identifier	University of Virginia IRB-HSR

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Mar 22, 2013

First Submission Date that Met QC Criteria

Mar 26, 2013

First Posted Date

Mar 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2024

Last Update Posted Date

Feb 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transoral robotic surgery	Experimental	Transoral robotic surgery	Procedure: Transoral robotic surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transoral robotic surgery	Procedure	Transoral robotic surgery using the daVinci robot to remove primary tumor	Transoral robotic surgery

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Overall survival	Measured from the date of surgery until date of death from any cause	3 years
Functional quality of life	Subject-reported functional outcome questionnaires will be used to quantify patient-reported speech and swallowing function

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Metastatic disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katherine L Fedder, MD	University of Virginia School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia Health System		Charlottesville	Virginia	22908	United States

Condition Browse Module

MeSH Terms

ID	Term
D000077195	Squamous Cell Carcinoma of Head and Neck
D002277	Carcinoma

Ancestor Terms

ID	Term
D002294	Carcinoma, Squamous Cell
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided