RecruitingPhase 2NCT06485778

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

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

24 participants

Start Date

Jun 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether radiation therapy after surgery is beneficial for people with early-stage squamous cell carcinoma of the tongue (mouth cancer) who have certain higher-risk features in their removed tumor, but do not have the most severe risk factors that typically require post-surgical radiation. **You may be eligible if...** - You are 18 or older - You had surgery that removed all visible cancer in your mouth/tongue - Your pathology report shows certain risk features such as lymphovascular invasion, tumor depth between 4–10mm, or 1-2 positive lymph nodes - Your surgical margins (distance from the cut edge to the cancer) are adequate (at least 3mm) **You may NOT be eligible if...** - Your cancer involves 3 or more lymph nodes - Cancer cells were found at or very close to the surgical edge (positive margins) - Cancer has broken out of a lymph node capsule (extracapsular extension) - You have extensive nerve invasion by the tumor - You have a serious autoimmune condition - You had a prior or simultaneous cancer that poses a similar risk of death Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONPhoton intensity modulated radiation therapy (IMRT)

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

OTHERLife questionnaire's

EORTC QLQ C30/HN 35 and MDADI


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 Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06485778


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