New radiation approach aims to ease head and neck cancer pain in fewer sessions
NCT ID NCT05674396
First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 3 times
Summary
This phase 2 trial tests whether a modern radiation technique called stereotactic body radiotherapy (SBRT) can safely deliver a strong dose of radiation in just 3 to 5 sessions to relieve symptoms from head and neck cancer. The study involves 108 adults whose cancer cannot be cured. Researchers will compare symptom changes using a standard questionnaire to see if the shorter course works better than traditional palliative radiation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stereotactic body radiation therapy (SBRT)
- What this could lead to
- If successful, this could offer a quicker, more effective way to reduce pain and other symptoms from head and neck cancer that cannot be cured.
- What could go wrong
- This is a small, early-phase trial (108 participants) testing a new radiation schedule. It may not prove better than standard palliative radiation, and stronger doses could increase side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 108 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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- Can steroid shots shield salivary glands from radiation damage?