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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2

Conditions: Oral Tongue Squamous Cell Carcinoma

Treatments: Other: Life questionnaire's; Radiation: Photon intensity modulated radiation therapy (IMRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06485778

24-167

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Radiation Therapy

Experimental group

Description:

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.

Treatment:

Radiation: Photon intensity modulated radiation therapy (IMRT)

Other: Life questionnaire's