Oral Tongue Squamous Cell CarcinomaPhase 2NCT06485778
A Study of Radiation Therapy After Surgery in People With Oral Tongue Squamous Cell Carcinoma
A Phase 2 study testing Photon intensity modulated radiation therapy (IMRT) and Life questionnaire's in people with Oral Tongue Squamous Cell Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Tongue Squamous Cell Carcinoma
- What is being tested?
- Photon intensity modulated radiation therapy (IMRT) and Life questionnaire's
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 Jun 2024to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nancy Lee, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Sean McBride, MD, MPH, 646-608-2450
- Recruiting
Memorial Sloan Kettering Suffolk - Commack
Commack, New York, 11725
Sean McBride, MD, 646-608-2450
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Sean McBride, MD, 646-608-2450
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Sean McBride, MD, 646-608-2450
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Sean McBride, MD, 646-608-2450
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Sean McBride, MD, 646-608-2450
Nancy Lee, MD, 212-639-3341
- Recruiting
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
Sean McBride, MD, 646-608-2450
About this study
Official title: Phase 2 Single Arm Trial of Adjuvant Nodal Irradiation Alone in Post Operative Oral Tongue Squamous Cell Carcinoma
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.
- Conditions
- Oral Tongue Squamous Cell Carcinoma
- Being tested
- Photon intensity modulated radiation therapy (IMRT), Life questionnaire's
- Keywords
- pT1-2,pN0-2b, intensity modulated radiation therapy (IMRT), 24-167
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon intensity modulated radiation therapy (IMRT)Radiation
Patients will receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions).
Life questionnaire'sOther
EORTC QLQ C30/HN 35 and MDADI
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy | Experimental | 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. Receives: Radiation: Photon intensity modulated radiation therapy (IMRT); Other: Life questionnaire's |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Acute Grade ≥3 Oral Mucositis
This is defined by CTCAE v 5.0 criteria
Measured: within 120 days of radiation completion
Secondary outcomes (1)
Cumulative Incidence of Local Failure
will be defined as any local failure in the oral tongue/FOM/BOT that is subsequently proven by biopsy during protocol-mandated follow-up. Competing risks will be distant or regional failure without local failure or death without progression. This will be calculated from the start of radiation.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start27 Jun 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Tongue Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 2 single arm trial enrolling post operative oral tongue squamous cell carcinoma patients with pT1-2N0-N2b.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean McBride, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485778
- Sponsor's protocol ID
- 24-167
- Status last verified
- May 2026
- First submitted
- 27 Jun 2024
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Single Arm Trial of Adjuvant Nodal Irradiation Alone in Post Operative Oral Tongue Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06485778
- Acronym / sponsor ID
- 24-167
- Conditions
- Oral Tongue Squamous Cell Carcinoma
- Keywords
- pT1-2,pN0-2b, intensity modulated radiation therapy (IMRT), 24-167
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 2 single arm trial enrolling post operative oral tongue squamous cell carcinoma patients with pT1-2N0-N2b.
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy | Experimental | Radiation: Photon intensity modulated radiation therapy (IMRT), Other: Life questionnaire'sThese 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photon intensity modulated radiation therapy (IMRT)Patients will receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions). | Radiation | Radiation Therapy |
| Life questionnaire'sEORTC QLQ C30/HN 35 and MDADI | Other | Radiation Therapy |
Primary outcome
Rate of Acute Grade ≥3 Oral Mucositis
Time frame: within 120 days of radiation completion
This is defined by CTCAE v 5.0 criteria
1 secondary outcome
Cumulative Incidence of Local Failure
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Related trials for Oral Tongue Squamous Cell Carcinoma
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Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
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Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Neck Squamous Cell Carcinoma of Unknown Primary, Recurrent Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 2/3
Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
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Active, not recruitingPhase 1/2
A Dye for the Detection of Cancer of the Tongue and Mouth
Oral Squamous Cell Carcinoma (OSCC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nancy Lee, MD contact
Sean McBride, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Photon intensity modulated radiation therapy (IMRT) and Life questionnaire's in people with Oral Tongue Squamous Cell Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sean McBride, MD, PhD (646-608-2450, mcbrides@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Acute Grade ≥3 Oral Mucositis (time frame: within 120 days of radiation completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.