The goal of this study is to evaluate if a shorter course of therapy can improve the quality of life in patients receiving radiation therapy after trans-oral robotic surgery.
Participant aged ≥ 18 years.
Diagnosis of oropharyngeal squamous cell carcinoma.
Eligible to receive transoral robotic surgery.
If status is known, p16 positivity or HPV positivity by in situ hybridization on pathological sampling of lymph node or primary oropharyngeal tumor. If status not known at the time of step-1 registration, otherwise eligible participants may be enrolled and HPV/p16 status must be determined prior to step-2 registration.
History of prior mucosal head and neck cancer treated with radiation therapy
Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this study
Participant has smoked cigarettes within 1 month of registration
Prior systemic anti-cancer therapy or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.
Parallel
Radiation Therapy
RadiationReduced dose and Hypofractionated radiation therapy
Stable or improved FACT-HN at 6 months post-treatment compared to baseline.
To evaluate if a shorter course of therapy can improve quality of life in patients receiving adjuvant radiation therapy after TORS.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
To assess the safety and tolerability of reduced-dose adjuvant radiation therapy in the study population.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0).
To assess the safety and tolerability of reduced-dose adjuvant radiation therapy in the study population.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
To assess the safety and tolerability of reduced-dose adjuvant radiation therapy in the study population.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.
To assess the safety and tolerability of reduced-dose adjuvant radiation therapy in the study population.
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