A Study of Radiation Therapy After Surgery in People With Oral Tongue Squamous Cell Carcinoma
NCT ID: NCT06485778
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
24 participants
INTERVENTIONAL
2024-06-27
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Radiation Therapy
These patients will then receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions). They will be monitored for both physician reported toxicities.
Photon intensity modulated radiation therapy (IMRT)
Patients will receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions).
Life questionnaire's
EORTC QLQ C30/HN 35 and MDADI
Interventions
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Photon intensity modulated radiation therapy (IMRT)
Patients will receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions).
Life questionnaire's
EORTC QLQ C30/HN 35 and MDADI
Eligibility Criteria
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Inclusion Criteria
* 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
* pT3 by size
* \>2 pathologically positive nodes
* Primary specimen surgical margin \< 3 mm
* 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.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Sean McBride, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Countries
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Central Contacts
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Nancy Lee, MD
Role: CONTACT
Facility Contacts
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Sean McBride, MD, MPH
Role: primary
Sean McBride, MD
Role: primary
Sean McBride, MD
Role: primary
Sean McBride, MD
Role: primary
Sean McBride, MD
Role: primary
Sean McBride, MD
Role: primary
Nancy Lee, MD
Role: backup
Sean McBride, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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24-167
Identifier Type: -
Identifier Source: org_study_id
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