This study is being done to answer the following question: Does stereotactic body radiation therapy (SBRT) provide better cancer control compared to standard radiation therapy (RT) for those with advanced head and neck cancer?
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
Patients with nasopharyngeal carcinoma.
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.
Parallel
Standard Radiotherapy (SRT)
Radiation2400 cGy in 3 fractions - day 0/7/21, OR, 2500 cGy in 5 fractions over 1 week
Stereotactic Body Radiotherapy (SBRT)
Radiation4500 cGy in 5 fractions (twice a week to primary and nodal GTV, OR, 4000 cGy in 5 fractions twice a week if organs at risk.
Overall Survival estimated according to Kaplan-Meier's methodology
Progression-free Survival
Local Regional Failure Free Survival
defined as the time from the date of randomization to the date of any of the following, whichever comes first: * The first record of appearance (radiological or clinical) of local or regional disease progression/recurrence. * Surgery of primary tumour at any time performed for clinical or radiological (RECIST 1.1) disease persistence/progression/recurrence with tumour present/unknown on final pathology. * Neck dissection \> 20 weeks from the end of radiation therapy performed for clinical or radiological (RECIST 1.1) disease persistence/progression/recurrence with tumour present/unknown on final pathology.
Response Rate evaluated by RECIST
Number and Severity of Adverse Events
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Canadian Cancer Trials Group
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
