Recruiting
Phase 2

IMRT

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06485778

Conditions

Oral Tongue Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Photon intensity modulated radiation therapy (IMRT)

Life questionnaire's

Study Details

Brief summary:

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

Study ID

NCT06485778

Start date

Jun 27, 2024

Status verified date

May, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Photon intensity modulated radiation therapy (IMRT)

Patients will receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions).

Life questionnaire's

EORTC QLQ C30/HN 35 and MDADI

Primary outcome measure

  • Rate of Acute Grade ≥3 Oral Mucositis [ Time Frame: within 120 days of radiation completion ]

Central Contacts and Locations

Central contacts

Sean McBride, MD, PhD

646-608-2450mcbrides@mskcc.org

Nancy Lee, MD

212-639-3341

Locations

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Sean McBride, MD, MPH

646-608-2450

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Sean McBride, MD

646-608-2450

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Sean McBride, MD

646-608-2450

Memorial Sloan Kettering Suffolk - Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Sean McBride, MD

646-608-2450

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Sean McBride, MD

646-608-2450

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Sean McBride, MD

646-608-2450

Nancy Lee, MD

212-639-3341

Principal Investigator:

Sean McBride, MD

Memorial Sloan Kettering Nassau

Recruiting

Uniondale, New York, United States, 11553

Contacts

Sean McBride, MD

646-608-2450

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • pT1-2,pN0-2b
  • intensity modulated radiation therapy (IMRT)
  • 24-167

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-29.