Aiming to spare the neck: could smarter radiation cut side effects in oral cancer?
NCT ID NCT07121595
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This phase II trial is testing whether a sentinel lymph node biopsy can guide radiation therapy to only one side of the neck in people with oral cavity squamous cell carcinoma. Currently, standard treatment often involves radiating both sides of the neck, which can harm saliva production, speech, and swallowing. By using the biopsy results to see if cancer has spread to lymph nodes, doctors hope to personalize radiation and spare the opposite side from unnecessary treatment. The study will measure how well this approach controls cancer recurrence in the neck and how it affects neck function and dryness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Personalized radiation therapy directed by sentinel lymph node biopsy
- What this could lead to
- If successful, this approach could allow many patients with oral cavity cancer to receive radiation only on the side of the tumor, sparing the other side and reducing side effects like dry mouth and swallowing problems.
- What could go wrong
- This is a small pilot study, so results may not be definitive. There is a risk that skipping radiation to the opposite side could lead to a higher chance of cancer returning there, and the procedure itself carries standard risks of biopsy and radiation.
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 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2030
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: * Patient must have biopsy-proven squamous cell carcinoma of the oral cavity * Clinical stage cT1-4a N0-2b M0 within 42 days of study enrollment based on the following work-up: * History and physical examination within 42 days of study enrollment; must include documentation of lateralized primary tumor site * Cross-sectional imaging of the head and neck within 42 days of study enrollment * Cross-sectional imaging of the chest within 42 days of study enrollment * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 within 42 days of study enrollment * Age \> 18 * Recommended treatment plan is surgical resection with ipsilateral neck dissection and SPECT-CT-guided sentinel node biopsy. Flap reconstruction is allowed * Patient is willing and able to provide informed consent. Patient provides study-specific informed consent prior to study entry * Women of childbearing potential and male participants must agree to use medically effect means of birth control throughout their participation in the treatment phase of the study Exclusion Criteria: * Evidence of distant metastatic disease based on clinical or radiologic evaluation * Evidence of contralateral neck disease on staging imaging * Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer, including effectively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix) unless disease free for ≥ 2 years * Diagnosis of head and neck squamous cell carcinoma (SCC) in the oropharynx, nasopharynx, hypopharynx, and larynx * Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowed. Prior immunotherapy for the study cancer is allowed. * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection * Pregnant and breast-feeding patients * Excisional biopsy for study cancer * Prior surgery involving the lateral neck, including neck dissection or gross injury to the neck that would preclude surgical dissection for this trial. Prior thyroid and central neck surgery is permissible; incisional biopsy is permitted * Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic leukemia \[CLL\]) or other active disease capable of causing lymphadenopathy (sarcoidosis or untreated mycobacterial infection) * Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy * Currently participating in another investigational therapeutic trial
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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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University of Michigan Comprehensive Cancer Center
RECRUITINGAnn Arbor, Michigan, 48109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a grid of proton beams boost immunotherapy against oral cancer?
- Can tumor genetics unlock gentler treatments for head and neck cancer?
- Can a Three-Pronged attack shrink Hard-to-Treat head and neck cancers?
- Less neck surgery may be just as effective for oral cancer with one affected node
- Bee product may boost health in oral cancer survivors
- Acupuncture timing may be key to preventing dry mouth in head and neck cancer patients