Could less radiation be better for head and neck cancer?
NCT ID NCT06477692
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with head and neck cancer. It compares two types of radiation therapy: one that treats only the cancer and nearby lymph nodes (INRT) and one that treats a larger area (ENI). The goal is to see if the smaller treatment area works just as well and causes fewer side effects like skin irritation. About 80 participants will take part.
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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 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Jul 2028
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 99 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: * Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed. * Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations. Diagnostic lymph node excision (≤ 2 nodes) is also allowable. * Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer. * Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded * Age ≥ 18 years. * ECOG Performance Status 0-2 * All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). * Neck CT and/or neck MRI, and PET-CT * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Distant metastasis. * Inability to undergo either a diagnostic CT with contrast or simulation CT with contrast. * Inability to undergo PET-CT. * Stage I and II glottic carcinoma. * Gross total excision of both the primary and nodal disease. * Synchronous non-skin cancer primaries outside of the oropharynx, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer; in the latter case, surgery may occur before or after treatment, provided all other eligibility criteria are met. * Prior invasive malignancy with an expected disease-free interval of less than 3 years. * Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable. * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields. * Subjects may not be receiving any other investigational agents. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary). * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements. * History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant.
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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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UT Southwestern Medical Center
RECRUITINGDallas, Texas, 75390, United States
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Other studies related to the condition(s) this trial covers.
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- Can a Self-Care program ease Post-Cancer swelling in the head and neck?
- Blood biomarkers may foreshadow Radiation-Induced dry mouth
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can a smart breathing device make life with a tracheostomy more comfortable?
- A simple dye might replace radioactive tracers in cancer staging