AI shrinks radiation target, cuts side effects in head and neck cancer
NCT ID NCT03953976
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new way to give radiation for head and neck cancer. Instead of treating the whole neck, doctors used artificial intelligence to focus radiation only on the cancer spots. 67 patients took part to see if this approach could reduce side effects without increasing the chance of cancer coming back.
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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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67 people
The number who actually took part.
- Started
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Jul 2019
- Finished
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Jan 2024
- 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: 1. Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed. 2. 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. 3. Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer. 4. Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded 5. Age ≥ 18 years. 6. ECOG Performance Status 0-2 7. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, 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. 7.1 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). 8. Negative serum pregnancy test within 2 weeks before registration for women of childbearing potential. 9. Neck CT and/or neck MRI, and PET-CT (at least skull-to-thigh). 10. Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: 1. Distant metastasis. 2. Inability to undergo PET-CT. 3. Stage I and II glottic carcinoma. 4. Gross total excision of both the primary and nodal disease. 5. 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 . 6. Prior invasive malignancy with an expected disease-free interval of less than 3 years. 7. Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable 8. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields. 9. Subjects may not be receiving any other investigational agents. 10. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary). 11. 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 12. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. 13. 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.
Contacts and locations
Locations
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University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390, United States
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Other studies related to the condition(s) this trial covers.
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