NCT06485778 · Memorial Sloan Kettering Cancer Center
A Study of Radiation Therapy After Surgery in People With Oral Tongue Squamous Cell Carcinoma
What this study is about
This study will test whether limiting standard photon intensity modulated radiation therapy (IMRT) to exclude the taken by mouth tongue surgical site can decrease the risk of side effects caused by taken by mouth radiation.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- DOI ≥ 4mm and ≤ 10mm OR
- 1 or 2 pathologically positive nodes N1 to low volume N2b. OR
- Primary specimen surgical margins ≥3 mm
- Signed informed consent form by the participant or their legally authorized representative (LAR) o DOI \>10 mm
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
- Surgery at outside institution (PI can give approval for patients operating on outside)
- Prior or simultaneous invasi
Where
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 29, 2026 · Source of record for eligibility and locations