3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial

To learn if it is effective to use advanced radiation treatment techniques (stereotactic radiation or "SBRT") to safely deliver a strong dose of radiation to your tumor in a shorter period of time than would typically be feasible with traditional methods.

Inclusion Criteria:Age 18 or olderWilling to provide informed consentHistologically confirmed squamous cell carcinomaPrimary tumor site in the head and neck (includes oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, salivary gland, and cutaneous subsites as well as tumors of unknown primary site)Ineligible for curative intent treatment after multidisciplinary evaluation (including evaluation by radiation oncologist and surgeon followed by presentation at multidisciplinary tumor board prior to randomization)Prior therapy including radiation, surgery, or systemic therapy is permitted unless further radiation is deemed inappropriate by the enrolling physicianMetastatic disease is permittedExclusion Criteria:Contraindications to radiotherapyPregnant or lactating women5.0 PRE-TREATMENT EVALUATIONHistory and physical examination including laryngopharyngoscopy by a radiation oncologist and/or head and neck surgeon within 8 weeks prior to randomization.o Clinical examination will include a detailed description of disease target including measurement where feasible to facilitate response assessmentDocumentation of smoking historyStaging imaging within 12 weeks prior to randomization:Contrast-enhanced CT of the neck and chest orMRI of the neck with CT of the chest orWhole body PET/CTHistological confirmation of squamous cell carcinomaPregnancy test for women of child-bearing age, within 2 weeks prior to randomizationAssessment of all baseline symptoms, using CTCAE version 5.0 within 2 weeks prior to randomization.Assessment of baseline pain score (NRS) and analgesic use (non-opioid and opioid)Completion of QOL scoring within 2 weeks of randomizationInformed consents must be obtained prior to any study specific activities