A Study of Radiation Therapy After Surgery in People With Oral Tongue Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Photon intensity modulated radiation therapy (IMRT), Life questionnaire's.
- Who it may be relevant to
- Registry conditions: Oral Tongue Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase 2 Single Arm Trial of Adjuvant Nodal Irradiation Alone in Post Operative Oral Tongue Squamous Cell Carcinoma
Overview
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.
Interventions
- Radiation Photon intensity modulated radiation therapy (IMRT)
Patients will receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions). - Other Life questionnaire's
EORTC QLQ C30/HN 35 and MDADI
Primary outcome measures
- Rate of Acute Grade ≥3 Oral Mucositis [Time frame: within 120 days of radiation completion]
Secondary outcome measures (1)
- Cumulative Incidence of Local Failure [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- N2c/N3 nodal disease
- pT3 by size
- >2 pathologically positive nodes
- Primary specimen surgical margin < 3 mm (if <WPOI 5, margin can be >= 2.2mm)
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Memorial Sloan Kettering Basking Ridge — Basking Ridge
- Memorial Sloan Kettering Monmouth — Middletown
- Memorial Sloan Kettering Bergen — Montvale
- Memorial Sloan Kettering Suffolk - Commack — Commack
- Memorial Sloan Kettering Westchester — Harrison
- Memorial Sloan Kettering Cancer Center — New York
- Memorial Sloan Kettering Nassau — Uniondale
Identifiers
NCT: NCT06485778 · 24-167