Phase II Study Comparing Stereotactic Body Radiation Therapy and Traditional Radiation for Palliative Treatment of Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating advanced radiation treatment techniques, specifically stereotactic body radiation therapy SBRT, for safely delivering a strong dose of radiation to tumors in patients with head and neck squamous cell carcinoma HN SCC who are not eligible for curative treatment. The trial aims to compare local progression-free survival, pain response, symptom burden, toxicity, local control, progression-free survival, and overall survival between SBRT and traditional radiation methods. This Phase II randomized trial explores if SBRT can provide effective palliation in a shorter treatment period than conventional approaches. Participants will be randomly assigned to receive either traditional radiation therapy or SBRT. Both treatments involve radiation delivered according to schedules discussed with the study doctor. The study focuses on comparing these two radiation methods for palliation in patients with HN SCC. Treatment details, including timing and dosage, will be managed individually by the medical team. The trial runs until September 2027, with treatment and follow-up planned over about one year. During the study, participants undergo evaluations such as symptom assessments using the M. D. Anderson Symptom Inventory for head and neck cancer MDASI-HN, pain scoring, quality of life questionnaires, and clinical examinations including imaging like CT, MRI, or PETCT scans. Baseline symptoms, smoking history, and pregnancy status for women of child-bearing age are checked before randomization. Researchers will monitor symptom burden and treatment responses throughout the trial, with data collection continuing for up to one year after treatment. Informed consent and regular clinical assessments support participant safety and data accuracy throughout the study.

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