Transoral Robotic Surgery or Standard Surgery in Treating Patients With Benign or Malignant Tumors of the Larynx and Pharynx
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer Perioperative/Postoperative Complications Precancerous Condition |
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 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study Assessing the Use of DA VINCI® Robotic Surgical System in Laryngeal and Pharyngeal Surgeries |
- Operative time that directly affects operative cost [ Designated as safety issue: No ]
- Blood loss [ Designated as safety issue: Yes ]
- Intra-operative and post-operative complications [ Designated as safety issue: Yes ]
- Need for reconstruction [ Designated as safety issue: No ]
- Margins status [ Designated as safety issue: No ]
- Length of hospital stay [ Designated as safety issue: No ]
- Tracheostomy and PEG dependence [ Designated as safety issue: No ]
- Days to oral intake [ Designated as safety issue: No ]
- Time to locoregional recurrence [ Designated as safety issue: No ]
- Speech intelligibility [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Postoperative pain [ Designated as safety issue: No ]
- Proportion of robotic surgical cases where adequate surgical exposure allowed for successful operation completion [ Designated as safety issue: No ]
| Enrollment: | 6 |
| Study Start Date: | May 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Principal Investigator: | Ho-Sheng Lin, MD | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Ho-Sheng Lin, Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00918762 History of Changes |
| Other Study ID Numbers: | CDR0000642940, P30CA022453, WSU-2008-022 |
| Study First Received: | June 9, 2009 |
| Last Updated: | March 12, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Barbara Ann Karmanos Cancer Institute:
|
perioperative/postoperative complications precancerous condition stage I squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the hypopharynx stage I squamous cell carcinoma of the larynx stage I verrucous carcinoma of the larynx stage II squamous cell carcinoma of the larynx stage II verrucous carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage III verrucous carcinoma of the larynx stage I lymphoepithelioma of the nasopharynx |
stage I squamous cell carcinoma of the nasopharynx stage II lymphoepithelioma of the nasopharynx stage II squamous cell carcinoma of the nasopharynx stage III lymphoepithelioma of the nasopharynx stage III squamous cell carcinoma of the nasopharynx stage I lymphoepithelioma of the oropharynx stage I squamous cell carcinoma of the oropharynx stage II lymphoepithelioma of the oropharynx stage II squamous cell carcinoma of the oropharynx stage III lymphoepithelioma of the oropharynx stage III squamous cell carcinoma of the oropharynx |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Postoperative Complications Precancerous Conditions |
Neoplasms by Site Neoplasms Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013