Status:
RECRUITING
A Study of Radiation Therapy After Surgery in People With Oral Tongue Squamous Cell Carcinoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Oral Tongue Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 radiati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06485778
Start Date
June 27 2024
End Date
June 1 2026
Last Update
October 24 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Suffolk - Commack
Commack, New York, United States, 11725