NCT06485778RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 27 Jun 2024
- Start date
- 27 Jun 2024
- Primary completion date
- Jun 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Head and neck cancer
- NCT number
- NCT06485778
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 24
- From 27 Jun 2024 to the primary completion date, Jun 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Primary specimen surgical margin \< 3 mm (if \<WPOI 5, margin can be \>= 2.2mm)
- 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.
Other illness
- N2c/N3 nodal disease
- Auto-immune conditions that would otherwise preclude radiation in the opinion of the PI (e.g. Scleroderma).
Other
- pT3 by size
- \>2 pathologically positive nodes
- Extensive Perineural Invasion (PNI); non-extensive PNI is permitted.
- Extra-capsular extension in any pathologically positive lymph node
- Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge Coordinator of this site? Confirm its status | Basking Ridge | United States | Recruiting |
| Memorial Sloan Kettering Suffolk - Commack Coordinator of this site? Confirm its status | Commack | United States | Recruiting |
| Memorial Sloan Kettering Westchester Coordinator of this site? Confirm its status | Harrison | United States | Recruiting |
| Memorial Sloan Kettering Monmouth Coordinator of this site? Confirm its status | Middletown | United States | Recruiting |
| Memorial Sloan Kettering Bergen Coordinator of this site? Confirm its status | Montvale | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan Kettering Nassau Coordinator of this site? Confirm its status | Uniondale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.