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

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06485778

Patient View

This study evaluates the impact of excluding the oral tongue surgical site from standard photon IMRT on side effects, recurrence, and quality of life in patients with oral tongue squamous cell carcinoma. Eligible participants are adults with specific pathologic risk features post-surgery. Interventions include targeted radiation and quality of life assessments using EORTC and MDADI questionnaires.

Patient Parameters

Program Overview

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.

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18

  • Surgical resection of all gross disease without evidence of residual loco-regional disease on simulation PET/CT.

  • pT1-2,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 OR

    • 1 or 2 pathologically positive nodes N1 to low volume N2b.

  • Primary specimen surgical margins ≥3 mm

  • Signed informed consent form by the participant or their legally authorized representative (LAR)

Exclusion Criteria

  • N2c/N3 nodal disease
  • >2 pathologically positive nodes
  • Primary specimen surgical margin < 3 mm
  • Extensive Perineural Invasion (PNI); non-extensive PNI is permitted.
  • Extra-capsular extension in any pathologically positive lymph node
  • Surgery at outside institution (PI can give approval for patients operating on outside)
  • 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.

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