Actively Recruiting
3-5 Fraction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial
Led by M.D. Anderson Cancer Center · Updated on 2026-02-19
108
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating advanced radiation treatment methods called stereotactic body radiotherapy (SBRT) to see if they can safely deliver a stronger dose of radiation to tumors in patients with head and neck squamous cell carcinoma (HN SCC) who are not eligible for curative treatment. The study compares SBRT with traditional radiation methods to understand differences in local tumor control, symptom relief, side effects, and survival outcomes. Participants are randomly assigned to receive either traditional palliative radiation or SBRT, with radiation schedules determined by the study doctor. This Phase II trial aims to deliver radiation in fewer sessions with SBRT, potentially shortening treatment time compared to standard fractionated radiation. During the study, participants will undergo symptom assessments using the M. D. Anderson Symptom Inventory for head and neck cancer over about one year. Researchers will monitor pain response, symptom burden, tumor progression, and overall safety. The trial includes regular clinical evaluations and imaging to assess treatment effects, and participation may last up to approximately one year or more depending on individual follow-up.
CONDITIONS
Brief Title
3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- Willing to provide informed consent
- Histologically confirmed squamous cell carcinoma
- Primary tumor site in the head and neck (including oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, salivary gland, cutaneous subsites, or unknown primary site)
- Ineligible for curative intent treatment after multidisciplinary evaluation
- Prior radiation, surgery, or systemic therapy allowed unless further radiation is inappropriate
- Metastatic disease allowed
You will not qualify if you...
- Contraindications to radiotherapy
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration depends on assigned radiation schedule
Participants receive radiation therapy either through stereotactic body radiotherapy (SBRT) or traditional fractionated palliation as per the schedule discussed with the study doctor.
Visits depend on radiation treatment schedule as discussed with the study doctor
Duration - Up to 1 year after treatment completion
Participants are monitored for symptom response, toxicity, local control, progression-free survival, and overall survival through approximately 1 year after treatment.
Regular follow-up visits over approximately 1 year
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jay Reddy, MD,PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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