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NCT06485778RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 29 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
24 (estimated)
First submitted
27 Jun 2024
Start date
27 Jun 2024
Primary completion date
Jun 2027
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT06485778

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 24
  • From 27 Jun 2024 to the primary completion date, Jun 2027
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Primary specimen surgical margin \< 3 mm (if \<WPOI 5, margin can be \>= 2.2mm)
  • 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.

Other illness

  • N2c/N3 nodal disease
  • Auto-immune conditions that would otherwise preclude radiation in the opinion of the PI (e.g. Scleroderma).

Other

  • pT3 by size
  • \>2 pathologically positive nodes
  • Extensive Perineural Invasion (PNI); non-extensive PNI is permitted.
  • Extra-capsular extension in any pathologically positive lymph node
  • Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Memorial Sloan Kettering Basking Ridge
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesRecruiting
Memorial Sloan Kettering Suffolk - Commack
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CommackUnited StatesRecruiting
Memorial Sloan Kettering Westchester
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HarrisonUnited StatesRecruiting
Memorial Sloan Kettering Monmouth
Coordinator of this site? Confirm its status
MiddletownUnited StatesRecruiting
Memorial Sloan Kettering Bergen
Coordinator of this site? Confirm its status
MontvaleUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Memorial Sloan Kettering Nassau
Coordinator of this site? Confirm its status
UniondaleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.