Clinical trial 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
- The study wants to know if skipping radiation on the part of the tongue that was operated on reduces side effects and whether it changes the chance of cancer coming back. It also looks at participants' quality of life.
- Who it's for
- People who have had surgery for oral tongue squamous cell carcinoma.
- What's involved
- Participants will receive a standard photon intensity‑modulated radiation therapy (IMRT) that does not target the surgical site, complete quality‑of‑life questionnaires, and have follow‑up visits to check for cancer recurrence.
- Time commitment
- The trial lasts for the duration of the radiation treatment period, with scheduled clinic visits and questionnaire sessions during and after therapy.
- 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.
- 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
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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at 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. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.