Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Tongue Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Life questionnaire's | Other | — | UNRESOLVED |
| Photon intensity modulated radiation therapy (IMRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation Therapy
- description
- These patients will then receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions). They will be monitored for both physician reported toxicities.
- interventionNames
- Radiation: Photon intensity modulated radiation therapy (IMRT)
- Other: Life questionnaire's
Primary outcomes (1)
- measure
- Rate of Acute Grade ≥3 Oral Mucositis
- timeFrame
- within 120 days of radiation completion
- description
- This is defined by CTCAE v 5.0 criteria
Secondary outcomes (1)
- measure
- Cumulative Incidence of Local Failure
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.References
Publications (0)
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