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

Description

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

Oral Tongue Squamous Cell Carcinoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Oral Tongue Squamous Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Basking Ridge

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States, 07920

Middletown

Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Suffolk - Commack, Commack, New York, United States, 11725

Harrison

Memorial Sloan Kettering Westchester, Harrison, New York, United States, 10604

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Uniondale

Memorial Sloan Kettering Nassau, Uniondale, New York, United States, 11553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age ≥ 18
  • * Surgical resection of all gross disease without evidence of residual loco-regional disease on simulation PET/CT.
  • * pT1-2,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 OR
  • * 1 or 2 pathologically positive nodes N1 to low volume N2b.
  • * Primary specimen surgical margins ≥3 mm
  • * Signed informed consent form by the participant or their legally authorized representative (LAR)
  • * N2c/N3 nodal disease
  • * \>2 pathologically positive nodes
  • * Primary specimen surgical margin \< 3 mm
  • * Perineural Invasion (PNI)
  • * Extra-capsular extension in any pathologically positive lymph node
  • * Surgery at outside institution (PI can give approval for patients operating on outside)
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Sean McBride, MD, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2026-06