Oropharyngeal Squamous Cell Carcinoma, Supraglottic Squamous Cell Carcinoma
Conditions
Keywords
Surgery, Robotic, Carcinoma, squamous cell of head and neck
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.
Interventions
PROCEDURETransoral robotic surgery
Transoral robotic surgery using the daVinci robot to remove primary tumor
Sponsors
Katherine L Fedder
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult male or female * Diagnosis of either oropharyngeal or supraglottic squamous cell carcinoma
Exclusion criteria
* Metastatic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 3 years | Duration of time from date of surgery to date of recurrence or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease specific survival | 3 years | Duration of time from the date of surgery until death with disease present |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3 years | Measured from the date of surgery until date of death from any cause |
| Functional quality of life | 3 years | Subject-reported functional outcome questionnaires will be used to quantify patient-reported speech and swallowing function |
| Incidence of adverse events | 3 years | Adverse events occuring following the surgery will be reported and graded using CTCAE v4.0 criteria |
Countries
United States
Outcome results
None listed