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Recruiting

NCT Number: NCT06485778

A Study of Radiation Therapy After Surgery in People With 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Photon intensity modulated radiation therapy (IMRT)

Radiation

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

Life questionnaire's

Other

EORTC QLQ C30/HN 35 and MDADI

Primary outcomes

  1. Rate of Acute Grade ≥3 Oral Mucositis

    Time frame: within 120 days of radiation completion

    This is defined by CTCAE v 5.0 criteria

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nancy Lee, MD

CONTACT

212-639-3341

Sean McBride, MD, PhD

CONTACT

[email protected]

646-608-2450

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 3, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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