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Radiation

Radiation Therapy for Tongue Cancer

Phase 2
Recruiting
Led By Sean McBride, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have at least two of the following pathologic risk features: LVI, DOI ≥ 4mm, or 1 or 2 pathologically positive nodes N1 to low volume N2b
Age ≥ 18
Must not have
Primary specimen surgical margin < 3 mm
Perineural Invasion (PNI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial will investigate if excluding the oral tongue surgical site from radiation therapy can reduce side effects in the mouth. Researchers will also examine if this approach impacts the likelihood of the disease returning after treatment and will

Who is the study for?
This trial is for individuals who have undergone surgery for oral tongue squamous cell carcinoma. Participants should be those who are now considering radiation therapy as the next step in their treatment.
What is being tested?
The study is testing a modified form of photon intensity modulated radiation therapy (IMRT) that avoids the surgical site on the oral tongue, aiming to reduce side effects and assess its impact on cancer recurrence and quality of life.
What are the potential side effects?
Potential side effects may include typical reactions to radiation such as soreness or ulceration in the mouth, difficulty swallowing, changes in taste, dry mouth, and fatigue. The study aims to see if avoiding the tongue reduces these issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has at least two high-risk features based on my pathology report.
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I am 18 years old or older.
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I had surgery to remove all visible cancer, and scans show no remaining local cancer.
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My tongue cancer is in an early stage and has not spread widely.
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My surgery removed the tumor with a clear margin of 3 mm or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer surgery margins were less than 3 mm.
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My cancer has spread along my nerves.
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My cancer has spread to certain lymph nodes.
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I have more than two lymph nodes with cancer.
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My cancer has spread outside the lymph node.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Acute Grade ≥3 Oral Mucositis
Secondary outcome measures
Cumulative Incidence of Local Failure

Trial Design

1Treatment groups
Experimental Treatment
Group I: Radiation TherapyExperimental Treatment2 Interventions
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.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,532 Total Patients Enrolled
Sean McBride, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
40 Total Patients Enrolled
~16 spots leftby Jun 2026
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