Head and Neck Squamous Cell CarcinomaPhase 2NCT05674396
3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial
A Phase 2 study testing Stereotactic body radiotherapy and Traditional Palliation in people with Head and Neck Squamous Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Stereotactic body radiotherapy and Traditional Palliation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2023to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Jay Reddy, MD, PHD, 832-750-2924, jreddy@mdanderson.org
Jay Reddy, MD, PHD
About this study
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.
Read the 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.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Stereotactic body radiotherapy, Traditional Palliation
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapyRadiation
Participants will receive radiation as per the schedule discussed with the study doctor.
Traditional PalliationRadiation
Participants will receive radiation as per the schedule discussed with the study doctor.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Palliation | Experimental | Participant will be randomized to standard radiation Receives: Radiation: Traditional Palliation |
| Stereotactic body radiotherapy (SBRT) | Experimental | Participants will be randomized to receive (SBRT) Stereotactic body radiotherapy. Receives: Radiation: Stereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires
- 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)
Measured: through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start30 Jun 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay Reddy, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674396
- Sponsor's protocol ID
- 2022-0648
- Other IDs
- NCI-2022-10828
- Status last verified
- Aug 2026
- First submitted
- 21 Dec 2022
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial
- ClinicalTrials.gov ID
- NCT05674396
- Acronym / sponsor ID
- 2022-0648
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Palliation | Experimental | Radiation: Traditional PalliationParticipant will be randomized to standard radiation |
| Stereotactic body radiotherapy (SBRT) | Experimental | Radiation: Stereotactic body radiotherapyParticipants will be randomized to receive (SBRT) Stereotactic body radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic body radiotherapyParticipants will receive radiation as per the schedule discussed with the study doctor. | Radiation | Stereotactic body radiotherapy (SBRT) |
| Traditional PalliationParticipants will receive radiation as per the schedule discussed with the study doctor. | Radiation | Traditional Palliation |
Primary outcome
M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires
Time frame: through 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jay Reddy, MD,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic body radiotherapy and Traditional Palliation in people with Head and Neck Squamous Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jay Reddy, MD,PHD ((832) 750-2924, jreddy@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires (time frame: through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.