Overview
To learn if it is effective to use advanced radiation treatment techniques (stereotactic radiation or "SBRT") to safely deliver a strong dose of radiation to your tumor in a shorter period of time than would typically be feasible with traditional methods.
Description
- 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.
Eligibility
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.
- 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