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

Inclusion Criteria:

* Age 18 or older
* Willing to provide informed consent
* Histologically confirmed squamous cell carcinoma
* Primary 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 physician
* Metastatic disease is permitted

Exclusion Criteria:

* Contraindications to radiotherapy
* Pregnant or lactating women

5.0 PRE-TREATMENT EVALUATION

* History 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 assessment
* Documentation of smoking history
* Staging imaging within 12 weeks prior to randomization:

  * Contrast-enhanced CT of the neck and chest or
  * MRI of the neck with CT of the chest or
  * Whole body PET/CT
* Histological confirmation of squamous cell carcinoma
* Pregnancy test for women of child-bearing age, within 2 weeks prior to randomization
* Assessment 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 randomization
* Informed consents must be obtained prior to any study specific activities