Could skipping radiation to the tongue reduce side effects without raising cancer risk?
NCT ID NCT06485778
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people who had surgery for oral tongue cancer and need radiation to prevent recurrence. Instead of radiating the whole mouth, doctors will only target the neck lymph nodes, sparing the tongue. The goal is to see if this reduces severe mouth sores while keeping the cancer from coming back. Twenty-four participants will also fill out quality-of-life questionnaires.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- photon intensity modulated radiation therapy (IMRT)
- What this could lead to
- If successful, this approach could reduce painful mouth sores from radiation while still preventing cancer from returning, improving quality of life for tongue cancer patients.
- What could go wrong
- This is a small, early-phase trial with only 24 participants, so results may not apply to all patients. There is a risk that limiting radiation could lead to higher recurrence rates.
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 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Jun 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 * Surgical resection of all gross disease without evidence of residual loco-regional disease on simulation PET/CT. * pT1-2, or pT3 by DOI, pN0-2b Squamous Cell Carcinoma of the Oral Tongue confirmed on final surgical pathology. Patients must have: * at least two of the following pathologic risk features * LVI * DOI ≥ 4mm and ≤ 10mm OR * 1 or 2 pathologically positive nodes N1 to low volume N2b. OR DOI \>10 mm OR * \<=cT3N2b who undergo induction with near pCR (\<5% viable) or pCR at primary site * Primary specimen surgical margins ≥3 mm (if \<WPOI 5, margin can be \>= 2.2mm) * Signed informed consent form by the participant or their legally authorized representative (LAR) Exclusion Criteria: * N2c/N3 nodal disease * pT3 by size * \>2 pathologically positive nodes * Primary specimen surgical margin \< 3 mm (if \<WPOI 5, margin can be \>= 2.2mm) * Extensive Perineural Invasion (PNI); non-extensive PNI is permitted. * Extra-capsular extension in any pathologically positive lymph node * Prior or simultaneous invasive malignancy that, in the opinion of the PI, represents a competing risk of death equivalent to the patient's oral tongue squamous cell carcinoma. * Auto-immune conditions that would otherwise preclude radiation in the opinion of the PI (e.g. Scleroderma). * Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.
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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
7 sites. 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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Memorial Sloan Kettering Basking Ridge
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering Suffolk - Commack
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Westchester
RECRUITINGHarrison, New York, 10604, United States
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