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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Radiation: Stereotactic body radiotherapy
* Radiation: Traditional Palliation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional Palliation<br>Participant will be randomized to standard radiation | Radiation: Traditional Palliation<br>* Participants will receive radiation as per the schedule discussed with the study doctor.<br>|
| Experimental: Stereotactic body radiotherapy (SBRT)<br>Participants will be randomized to receive (SBRT) Stereotactic body radiotherapy. | Radiation: Stereotactic body radiotherapy<br>* Participants will receive radiation as per the schedule discussed with the study doctor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires | M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) score range from 0/10 (0-symptom has not been present)0 to 10 (10-the symptom was as bad as you can imagine it could be) | through study completion; an average of 1 year. |