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

Objectives:

• To compare local progression-free survival following palliation with SBRT versus traditional fractionations in patients with HN SCC deemed ineligible for curative-intent treatment.
• To compare pain response, symptom burden, toxicity, local control, progression-free survival, and overall survival between the treatment modalities.

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