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RecruitingInterventionalPhase 2

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

NCT ID: NCT06485778Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-05-29

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.

Arms & interventions

  • RadiationPhoton intensity modulated radiation therapy (IMRT)

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

  • OtherLife questionnaire's

    EORTC QLQ C30/HN 35 and MDADI

Outcome measures

Primary

  • Rate of Acute Grade ≥3 Oral Mucositis

    This is defined by CTCAE v 5.0 criteria

    Time frame: within 120 days of radiation completion

Secondary

  • Cumulative Incidence of Local Failure

    Time frame: 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (7)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920

Recruiting
Sean McBride, MD, MPH · Contact

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748

Recruiting
Sean McBride, MD · Contact

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645

Recruiting
Sean McBride, MD · Contact

Memorial Sloan Kettering Suffolk - Commack

Commack, New York, 11725

Recruiting
Sean McBride, MD · Contact

Memorial Sloan Kettering Westchester

Harrison, New York, 10604

Recruiting
Sean McBride, MD · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Sean McBride, MD · Contact
Nancy Lee, MD · Contact
Sean McBride, MD · Principal Investigator

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553

Recruiting
Sean McBride, MD · Contact