NCT06485778 A Study of Radiation Therapy After Surgery in People With Oral Tongue Squamous Cell Carcinoma
| NCT ID | NCT06485778 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Oral Tongue Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-06-27 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2024-06-27 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Sean McBride, MD, PhD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT06485778 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oral Tongue Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06485778 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06485778 currently recruiting?
Yes, NCT06485778 is actively recruiting participants. Contact the research team at mcbrides@mskcc.org for enrollment information.
Where is the NCT06485778 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT06485778 clinical trial?
NCT06485778 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Sean McBride, MD, PhD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 24 participants.