Palliative Steroeotactic Body Radiotherapy vs Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer

Prior treatment

• Prior systemic therapy (including immunotherapy).
• Prior radiotherapy to the head and neck excluding superficial radiotherapy for head and neck skin cancer that does not overlap with current protocol treatment.
• Prior head and neck cancer excluding skin cancer.

Other illness

• Scleroderma/CREST syndrome.

Other

• Patients with nasopharyngeal carcinoma.
• Patients with tumour locations/at risk of SBRT toxicity, including glottic/subglottic larynx, T4 hypopharynx, post-cricoid, cervical esophagus, circumferential pharyngeal involvement, extension/proximity to brain/optic structures, any single tumour mass \>8 cm (in one dimension).
• \> 2 nodal levels (Level 1a/b not counted); retropharyngeal lymph nodes (where the closest edge is \< 2cm from the closest edge of CTV (primary or nodal) will not be considered as a different level). Note: a single lymph node mass that spans 2 levels will be considered as 1 level.
• Gross tumour poorly visualized on CT/MRI.
• Definitive radiological or clinically evident distant metastases.

• Histologically confirmed mucosal squamous cell carcinoma (SCC) of the head and neck arising from at least one of the following sites: oro/hypopharynx, oral cavity, supraglottic larynx, maxillary sinus, nasal cavity, or unknown primary
• Stages TX or T0-T4/N0-N3
• Must be considered unfit for curative intent RT as determined by the treating oncologist(s)
• Geriatric 8 score \<14
• Patient must be ≥18 years of age
• Staging CT or MRI of the head and neck within 8 weeks prior to randomization
• Chest CT or x-ray. PET CT is permitted if CT is of diagnostic quality.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
• Participants of childbearing potential must have agreed to use a highly effective contraceptive method during protocol therapy.
• Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational treatment are eligible for this trial.