Testing radiation therapy after surgery for oral tongue cancer
Phase 2 Single Arm Trial of Adjuvant Nodal Irradiation Alone in Post Operative Oral Tongue Squamous Cell Carcinoma
PHASE2 · Memorial Sloan Kettering Cancer Center · NCT06485778
This study is testing if a special type of radiation therapy that avoids the surgery area can help people with oral tongue cancer have fewer side effects and lower chances of the cancer coming back after surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center (other) |
| Drugs / interventions | radiation |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06485778 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of limiting photon intensity modulated radiation therapy (IMRT) to exclude the surgical site of the oral tongue in patients who have undergone surgery for squamous cell carcinoma. The goal is to determine if this targeted approach can reduce side effects associated with oral radiation while also assessing its impact on disease recurrence rates. Participants will complete quality of life questionnaires to provide insights into their experiences during treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone surgical resection of oral tongue squamous cell carcinoma with specific pathologic risk features.
Not a fit: Patients with extensive nodal disease or those with certain pathologic features that indicate a higher risk of complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer side effects for patients undergoing treatment for oral tongue cancer.
How similar studies have performed: Other studies have shown promise in using targeted radiation therapy approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
* 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.
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Suffolk - Commack — Commack, New York, United States (RECRUITING)
- Memorial Sloan Kettering Westchester — Harrison, New York, United States (RECRUITING)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
- Memorial Sloan Kettering Nassau — Uniondale, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Sean McBride, MD, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Sean McBride, MD, PhD
- Email: mcbrides@mskcc.org
- Phone: 646-608-2450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oral Tongue Squamous Cell Carcinoma, pT1-2,pN0-2b, intensity modulated radiation therapy, 24-167