At a glance
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Phase II Treatment Stratification Trial Using Neck Dissection-Driven Selection to Improve Quality of Life for Low Risk Patients With HPV+ Oropharyngeal Squamous Cell Cancer
In Brief
A Phase 2 clinical trial evaluating Neck Dissection, Standard-of-Care (SOC) Transoral Surgery of Primary Site, and 4 other interventions for Oropharyngeal Squamous Cell Cancer. Completed, enrolled 40 participants across 1 site.
Detailed Summary
Investigators will determine whether a treatment paradigm of up-front neck dissection, to more accurately pathologically stage patients, minimizing the number of treatment modalities in patients with low risk oropharyngeal squamous cell carcinoma, can improve quality of life.
Study Details
Timeline
Interventions
All patients will undergo neck dissection of the cervical lymph nodes
Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site.
Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation.
Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel).
Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel).
All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.