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A Study of Radiation Therapy After Surgery in People With Oral Tongue Squamous Cell Carcinoma

RecruitingPhase 2

Phase 2 Single Arm Trial of Adjuvant Nodal Irradiation Alone in Post Operative Oral Tongue Squamous Cell Carcinoma

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

This study will test whether limiting standard photon intensity modulated radiation therapy (IMRT) to exclude the oral tongue surgical site can decrease the risk of side effects caused by oral radiation. The researchers will also find out if this approach affects the rate of disease coming back after treatment (recurrence), and will measure participants' quality of life by having them complete questionnaires.

What is being tested

Sponsor: Memorial Sloan Kettering Cancer Center · Participants: 24 · Started: Jun 27, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06485778

Locations in the U.S.

New JerseyMemorial Sloan Kettering Basking Ridge, Basking Ridge
Memorial Sloan Kettering Monmouth, Middletown
Memorial Sloan Kettering Bergen, Montvale
New YorkMemorial Sloan Kettering Suffolk - Commack, Commack
Memorial Sloan Kettering Westchester, Harrison
Memorial Sloan Kettering Cancer Center, New York
Memorial Sloan Kettering Nassau, Uniondale

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.