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New treatment option for Oral Tongue Squamous Cell Carcinoma
Official title A Study of Radiation Therapy After Surgery in People With Oral Tongue Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06485778
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- DOI ≥ 4mm and ≤ 10mm OR
You likely can't join if
- N2c/N3 nodal disease
- pT3 by size
- \>2 pathologically positive nodes
- Primary specimen surgical margin \ = 2.2mm)
- Extensive Perineural Invasion (PNI); non-extensive PNI is permitted.
- Extra-capsular extension in any pathologically positive lymph node
See the full eligibility 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
- 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 \ = 2.2mm)
- Signed informed consent form by the participant or their legally authorized representative (LAR)
- N2c/N3 nodal disease
- pT3 by size
- \>2 pathologically positive nodes
- Primary specimen surgical margin \ = 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.