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

May 28, 2026 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nancy Lee, MD
  • Phone Number: 212-639-3341

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Contact:
          • Sean McBride, MD, MPH
          • Phone Number: 646-608-2450
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Contact:
          • Sean McBride, MD
          • Phone Number: 646-608-2450
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Contact:
          • Sean McBride, MD
          • Phone Number: 646-608-2450
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk - Commack
        • Contact:
          • Sean McBride, MD
          • Phone Number: 646-608-2450
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Sean McBride, MD
          • Phone Number: 646-608-2450
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Sean McBride, MD
        • Contact:
          • Nancy Lee, MD
          • Phone Number: 212-639-3341
        • Contact:
          • Sean McBride, MD
          • Phone Number: 646-608-2450
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Contact:
          • Sean McBride, MD
          • Phone Number: 646-608-2450

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Radiation: Photon intensity modulated radiation therapy (IMRT)
Patients will receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions).
Other: Life questionnaire's
EORTC QLQ C30/HN 35 and MDADI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Acute Grade ≥3 Oral Mucositis
Time Frame: within 120 days of radiation completion
This is defined by CTCAE v 5.0 criteria
within 120 days of radiation completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Incidence of Local Failure
Time Frame: 2 years
will be defined as any local failure in the oral tongue/FOM/BOT that is subsequently proven by biopsy during protocol-mandated follow-up. Competing risks will be distant or regional failure without local failure or death without progression. This will be calculated from the start of radiation.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Sean McBride, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-167

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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