Head and Neck Cancer Clinical Trial
Official title:
A Pilot Study Assessing the Use of DA VINCI® Robotic Surgical System in Laryngeal and Pharyngeal Surgeries
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
- 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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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