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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-02169 | Registry Identifier | NCI CTRP |
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The study will be rewritten as a data registry study
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Transoral robotic surgery (TORS) is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies how transoral robotic surgery works in treating patients with benign or stage I-IV head and neck cancer.
PRIMARY OBJECTIVES: To conduct a pilot study at City of Hope (COH) which assesses the feasibility and safety of TORS (Transoral robotic surgery), including: total operative time, blood loss, hospitalization time, need to convert to an open procedure, intra-operative as well as post-operative complications. SECONDARY OBJECTIVES: I. To collect data on oncologic outcomes, disease free survival, local control rate and overall survival. II. To collect normative data regarding objective functional outcomes (FO) which may impact quality of life in patients undergoing TORS, including need for adjunctive procedures, such as gastrostomy tube placement and tracheostomy placement, and with regards to speech, swallowing function and pain, using patient-report outcomes instruments. OUTLINE: Patients undergo transoral robotic microsurgery. After completion of study treatment, patients are followed up periodically for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients undergo transoral robotic microsurgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transoral robotic surgery | Procedure | Undergo transoral robotic microsurgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the feasibility of Transoral Robotic Surgery (TORS) in improving transoral accessibility within the upper aerodigestive tract in patients with benign or malignant head and neck tumors | From 6 months to 3 years after completion of study treatment | |
| Assessment of the total operative time to perform transoral surgery using TORS in patients with benign or malignant head and neck tumors | From 6 months to 3 years after completion of study treatment | |
| Assessment of blood loss during transoral surgery using TORS in patients with benign or malignant head and neck tumors | From 6 months to 3 years after completion of study treatment | |
| Assessment of hospitalization time of in patients with benign or malignant head and neck tumors undergoing transoral surgery using TORS | From 6 months to 3 years after completion of study treatment | |
| Assessment of the need to convert to an open procedure during transoral surgery using TORS in patients with benign or malignant head and neck tumors | From 6 months to 3 years after completion of study treatment | |
| Assessment of complications of transoral surgery using TORS in patients with benign or malignant head and neck tumors | From 6 months to 3 years after completion of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of data on oncologic outcomes, disease free survival, local control rate and overall survival. | From 6 months to 3 years after completion of study treatment | |
| Assessment of quality of life outcomes in patients undergoing TORS using patient-report outcomes instruments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellie Maghami | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| laboratory biomarker analysis |
| Other |
Correlative studies |
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| quality-of-life assessment | Procedure | Ancillary studies |
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| From 6 months to 3 years after completion of study treatment |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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