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FAST Phase II Trial for Head and Neck Cancer Palliation

This study is testing two types of radiation treatment for head and neck squamous cell carcinoma (a type of cancer that starts in flat cells). You might be able to join if you are 18 or older, have this type of cancer in your head and neck, and are not eligible for treatment aimed at curing your cancer. The study compares Stereotactic Body Radiotherapy (SBRT) with traditional radiation to see if SBRT can deliver a strong dose of radiation in a shorter time. Researchers want to see if SBRT helps with pain, other symptoms, and how long the cancer is controlled. The main way success will be measured is by looking at your symptoms using questionnaires over about one year. The current status of this study is unclear, and it plans to enroll 108 participants.

Study design
This is an interventional study that plans to enroll 108 participants. It compares two different radiation treatments: Stereotactic Body Radiotherapy (SBRT) and Traditional Palliation.
What's involved
Participants will receive radiation as discussed with the study doctor. Symptoms will be measured using questionnaires through study completion, which is an average of one year.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for an average of one year to complete symptom questionnaires.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05674396

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~108 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Stereotactic body radiotherapyTraditional Palliation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires
Measured over through study completion; an average of 1 year.

Conditions

Head and Neck Squamous Cell Carcinoma

Explore related trials

Head and Neck Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Jay Reddy, MD,PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Jay Reddy, MD,PHD
[email protected]
(832) 750-2924
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Contraindications to radiotherapy
Pregnant or lactating women
History and physical examination including laryngopharyngoscopy by a radiation oncologist and/or head and neck surgeon within 8 weeks prior to randomization.
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

What this trial measures

  • M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnairesthrough study completion; an average of 1 year.

    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)