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NCT05674396PHASE2Recruiting

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

M.D. Anderson Cancer Center

Start Date

6/30/2023

Completion Date

9/30/2027

Summary

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

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

RADIATION

Stereotactic body radiotherapy

RADIATION

Traditional Palliation

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Conditions

Head and Neck Squamous Cell Carcinoma

Locations

M D Anderson Cancer Center

Houston, Texas 77030

United States