Status:
COMPLETED
Transoral Robotic Surgery or Standard Surgery in Treating Patients With Benign or Malignant Tumors of the Larynx and Pharynx
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Perioperative/Postoperative Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 tran...
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 dis...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00918762
Start Date
May 1 2009
End Date
October 1 2010
Last Update
May 9 2014
Active Locations (1)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379