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

Recruiting now · Phase 2

Conditions studied: Head and Neck Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT05674396

Run by

M.D. Anderson Cancer Center

People needed

108

Starts

2023-06-30

Expected to finish

2027-09-30

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Contraindications to radiotherapy
• Pregnant or lactating women
• 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

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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