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

Phase 2

Recruiting

• Conditions: Oral Tongue Squamous Cell Carcinoma
• Interventions: Radiation: Photon intensity modulated radiation therapy (IMRT); Other: Life questionnaire's

• Registration Number: NCT06485778
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-27
• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Study First Posted: 2024-07-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiation Therapy	Photon intensity modulated radiation therapy (IMRT)	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.
Radiation Therapy	Life questionnaire's	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.

Primary Outcome Measures

Name	Time	Method
Rate of Acute Grade ≥3 Oral Mucositis	within 120 days of radiation completion	This is defined by CTCAE v 5.0 criteria

Secondary Outcome Measures

Name	Time	Method
Cumulative Incidence of Local Failure	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.

Trial Locations

Locations (7)

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen; 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau; 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 West Harrison, New York, United States