New shorter radiation regimen aims to cut treatment time for head and neck cancer patients
NCT ID NCT07507058
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial is testing a shorter, higher-dose radiation schedule (hypofractionated radiotherapy) for people with intermediate-risk head and neck cancer who have had surgery. The goal is to see if this 3-week course is safe and effective at controlling the cancer while possibly reducing side effects. The study will enroll 60 adults with stage II-IVA head and neck squamous cell carcinoma.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hypofractionated radiotherapy (higher-dose radiation given over 3 weeks instead of the usual longer course)
- What this could lead to
- If successful, this could offer a more convenient and potentially less toxic radiation option for patients with intermediate-risk head and neck cancer after surgery.
- What could go wrong
- This is a small, early-phase trial (60 participants) with no comparison group, so results may not apply broadly. The higher daily radiation dose could increase late 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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
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 to 100 years
- 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 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Histologically or cytologically confirmed stage II-IVA head and neck squamous cell carcinoma (AJCC 8th edition), including oral cavity, oropharynx, hypopharynx, larynx, or cervical lymph node metastasis from unknown primary * R0 resection and standard neck dissection per surgical evaluation * Negative surgical margins and no extranodal extension in metastatic lymph nodes on postoperative pathology * Presence of at least one intermediate-risk factor: close margins (\<5 mm), pT3-4, pN2, lymphovascular invasion, perineural invasion, poor differentiation, or for oral cavity cancer T2 with depth of invasion \>5 mm * Adequate organ function (without blood transfusion or growth factors within 14 days): * White blood cell count ≥ 2.0 × 10\^9/L * Absolute neutrophil count ≥ 1.0 × 10\^9/L * Platelet count ≥ 80 × 10\^9/L * Hemoglobin ≥ 90 g/L * Willing and able to comply with study and follow-up procedures * Voluntary participation with written informed consent Exclusion Criteria: * Prior radiotherapy or surgery to the head and neck region * Primary head and neck cancer arising from other sites such as paranasal sinuses, nasopharynx, glottic larynx, skin, or salivary glands * Concurrent other anti-tumor therapy * Prior neoadjuvant drug therapy * Evidence of tumor progression on imaging within 28 days before enrollment * History of severe infection within 1 month before enrollment, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia; any active infection, or unexplained fever \>38.5°C during screening or before first dose * Severe cardiovascular disease: grade II or higher myocardial ischemia or infarction, uncontrolled arrhythmia (including QTc interval ≥450 ms for males or ≥470 ms for females); New York Heart Association (NYHA) class III-IV heart failure, or left ventricular ejection fraction (LVEF) ≤50% on echocardiography * History of other malignancy within 5 years (except adequately treated in situ cervical cancer or basal cell/squamous cell carcinoma of the skin) * History of psychoactive substance abuse that cannot be abstained from, or mental disorders
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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 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
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