Testing radiation therapy after surgery for oral tongue cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of limiting photon intensity modulated radiation therapy (IMRT) to exclude the surgical site of the oral tongue in patients who have undergone surgery for squamous cell carcinoma. The goal is to determine if this targeted approach can reduce side effects associated with oral radiation while also assessing its impact on disease recurrence rates. Participants will complete quality of life questionnaires to provide insights into their experiences during treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Memorial Sloan Kettering Basking Ridge
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk - Commack
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Sean McBride, MD, PhD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Sean McBride, MD, PhD
• Email: mcbrides@mskcc.org
• Phone: 646-608-2450

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.