Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06485778

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

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-04

24

Participants Needed

7

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Surgical removal of all visible oral tongue cancer with no remaining local or regional disease on PET/CT
  • Oral tongue squamous cell carcinoma classified as pT1-2 or pT3 by depth of invasion, and pN0-2b confirmed by pathology
  • Presence of at least two risk factors: lymphovascular invasion, depth of invasion between 4mm and 10mm, or 1 or 2 positive lymph nodes (N1 to low volume N2b)
  • Primary surgical margins of 3 mm or greater (or 2.2 mm or greater if worst pattern of invasion is less than 5)
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Nodal disease classified as N2c or N3
  • Tumor classified as pT3 by size
  • More than 2 positive lymph nodes
  • Primary surgical margins less than 3 mm
  • Extensive perineural invasion (non-extensive allowed)
  • Extra-capsular extension in any positive lymph node
  • Prior or simultaneous invasive cancer posing similar or higher death risk
  • Autoimmune conditions preventing radiation (e.g., Scleroderma)
  • Inability or unwillingness to provide informed consent or complete questionnaires

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Suffolk - Commack

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau

Uniondale, New York, United States, 11553

Actively Recruiting

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Research Team

S

Sean McBride, MD, PhD

CONTACT

N

Nancy Lee, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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