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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA022453 | U.S. NIH Grant/Contract | View source | |
| WSU-2008-022 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Transoral robotic surgery may make it easier to find and remove benign or malignant tumors of the larynx and pharynx and cause less damage to normal tissue. It is not yet known whether transoral robotic surgery is more effective than standard surgery in diagnosing and treating larynx and pharynx tumors.
PURPOSE: This phase I trial is studying how well transoral robotic surgery works compared with standard surgery in treating patients with benign or malignant tumors of the larynx or pharynx.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are assigned to transoral robotic surgery or standard therapy consisting of conventional transoral endoscopic or open approach according to their preference.
Patients undergo planned surgical procedures (either diagnostic or therapeutic) appropriate for their disease in the larynx or pharynx via the transoral robotic surgical approach or the conventional transoral endoscopic or open approach.
Patients complete the Functional Assessment of Cancer Therapy Head and Neck Scale, the Performance Status Scale for Head and Neck Cancer Patients, and the University of Washington Quality of Life Scale at baseline and at 3 and 6 months. Patients also undergo voice analysis by acoustic analyses, and speech and swallow pathology evaluation by videostroboscopy and modified barium swallow.
After completion of study procedure, patients are followed at 3 and 6 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued to the control group (standard conventional surgery) and 30 patients will be accrued to the robotic surgery group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| daVinci® Robotic Surgical System | Experimental | Participants will undergo a planned surgical procedures via the robotic approach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| assessment of therapy complications | Procedure |
| ||
| diagnostic endoscopic surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time that directly affects operative cost | post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss | During surgery | |
| Intra-operative and post-operative complications | during the operation and post operative | |
| Need for reconstruction |
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DISEASE CHARACTERISTICS:
Benign or malignant disease of the larynx or pharynx that requires surgical intervention for either diagnostic or therapeutic purposes
Malignant disease must meet the following criteria:
Histologically confirmed diagnosis of 1 of the following:
Resectable involved lymph nodes
No invasion of osseous and/or osseocartilaginous structures including the following:
No pharyngeal wall or tongue-based involvement requiring resection of > 50% of the posterior pharyngeal wall or tongue base
No radiological confirmation of carotid artery involvement
No fixation of tumor to the prevertebral fascia
No bilateral arytenoid involvement
No surgical defect requiring open approach for reconstruction
No evidence of distant metastasis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Ho-Sheng Lin, MD | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
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| Procedure |
|
| quality-of-life assessment | Procedure |
|
| therapeutic conventional surgery | Procedure |
|
| therapeutic endoscopic surgery | Procedure |
|
| transoral robotic surgery | Procedure |
|
| video-assisted surgery | Procedure |
|
| post operative |
| Margins status | post operative |
| Length of hospital stay | during time as inpatient |
| Tracheostomy and PEG dependence | post operative |
| Days to oral intake | post operative |
| Time to locoregional recurrence | post operative |
| Speech intelligibility | post operative |
| Quality of life | 3 months and 6 month following completion of surgery |
| Postoperative pain | post operative |
| Proportion of robotic surgical cases where adequate surgical exposure allowed for successful operation completion | post operative |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D011183 | Postoperative Complications |
| D011230 | Precancerous Conditions |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D020535 | Video-Assisted Surgery |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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