Transoral Robotic Surgery or Standard Surgery in Treating Patients With Benign or Malignant Tumors of the Larynx and Pharynx
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
OBJECTIVES:
Primary
- Evaluate the potential benefits of using the transoral robotic surgical approach against the conventional open and transoral approaches in patients with benign or malignant disease involving the larynx and pharynx.
Secondary
- Determine the proportion of laryngeal and pharyngeal surgical procedures where the surgical exposure is adequate to allow the successful completion of the surgical resection using the transoral robotic surgical approach.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: daVinci® Robotic Surgical System Participants will undergo a planned surgical procedures via the robotic approach. |
Procedure: assessment of therapy complications
Procedure: diagnostic endoscopic surgery
Procedure: quality-of-life assessment
Procedure: therapeutic conventional surgery
Procedure: therapeutic endoscopic surgery
Procedure: transoral robotic surgery
Procedure: video-assisted surgery
|
Outcome Measures
Primary Outcome Measures
- Operative time that directly affects operative cost [post operative]
Secondary Outcome Measures
- Blood loss [During surgery]
- Intra-operative and post-operative complications [during the operation and post operative]
- Need for reconstruction [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]
Eligibility Criteria
Criteria
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:
-
Glottic cancer (T1, T2, and T3)
-
Supraglottic cancer (T1, T2, and T3)
-
Hypopharyngeal cancer (T1 and T2)
-
Oropharyngeal cancer (T1, T2, and T3)
-
Nasopharyngeal cancer (T1 and T2)
-
Resectable involved lymph nodes
-
No invasion of osseous and/or osseocartilaginous structures including the following:
-
Mandibular bone
-
Thyroid cartilage
-
Hyoid bone
-
Cricoid bone
-
Vertebral body
-
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:
-
Not pregnant
-
No unexplained fever and/or untreated active infection
-
No medical conditions contraindicating general anesthesia
-
No inadequate jaw opening due to prior head and neck surgery, trauma, or radiotherapy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201-1379 |
Sponsors and Collaborators
- Barbara Ann Karmanos Cancer Institute
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Ho-Sheng Lin, MD, Barbara Ann Karmanos Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000642940
- P30CA022453
- WSU-2008-022