SBRTA Study of SBRT for Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria:

1. Age >= 60 years
2. Histologically confirmed diagnosis of squamous cell carcinoma of the head and neck region including primary skin SCC; (malignant cells with suspicious/likely SCC will be considered for study if repeat biopsy is not feasible)
3. Clinical stage ≥ T2, or any T-stage with N1-N3 disease, M0 or Mx
4. Measurable tumour present in the head and neck region on clinical examination and/or imaging at time of study enrollment
5. All patients will be assessed by a multi-disciplinary, head and neck oncology team with no systemic therapy being recommended at the time of enrollment
6. Primary surgery not recommended/performed due to any of the following:

• Unresectable disease and/or borderline resectable
• Medically inoperable / deemed high risk for post-operative morbidity/mortality by surgical team
• Patient declined surgery

7. Deemed not to be a candidate for standard fractionation radiotherapy due to poor performance status and/or medical co-morbidities and/or advanced stage disease
8. Eastern Co-operative Oncology Group (ECOG) Performance Status ≤ 3

Exclusion Criteria:

1. Life expectancy ≤ 3 months
2. Chemotherapy or other systemic cancer therapy within 3 months prior to HN SBRT
3. Basal cell carcinoma, Merkel cell, malignant melanoma, adenocarcinoma are excluded
4. HN surgery within 6 months prior to HN SBRT (excision under local anaesthesia is acceptable)
5. Prior radiation treatment to the head and neck region (prior radiotherapy to the skin for non-melanoma skin cancer and deemed to have no risk of overlap with the current field are eligible)
6. Synchronous or recent cancer diagnosis not including the index cancer (other cancers treated curatively with no evidence of disease for >=3 years, or other non- melanoma skin cancers treated with no evidence of disease for >= 6 months are eligible)
7. Confirmed or known distant metastatic disease.
8. Serious non-malignant disease that precludes definitive radiation treatment (e.g.

severe cases of scleroderma, systemic lupus erythematosus, rheumatoid arthritis)
9. Unable to provide written, informed consent or complete QoL questionnaires and assessments required on the study
10. Unable to lie flat for 60 minutes in order to have radiation planning and treatment
11. Unable to attend radiation planning and therapy, as well as follow-up care and assessments
12. Unable to provide written, informed consent