A Study of Radiation Therapy After Surgery in People With Oral Tongue Squamous Cell Carcinoma
Phase 2 Single Arm Trial of Adjuvant Nodal Irradiation Alone in Post Operative Oral Tongue Squamous Cell Carcinoma
1 other identifier
interventional
24
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2024
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2024
CompletedStudy Start
First participant enrolled
June 27, 2024
CompletedFirst Posted
Study publicly available on registry
July 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
February 4, 2026
January 1, 2026
1.9 years
June 27, 2024
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Acute Grade ≥3 Oral Mucositis
This is defined by CTCAE v 5.0 criteria
within 120 days of radiation completion
Secondary Outcomes (1)
Cumulative Incidence of Local Failure
2 years
Study Arms (1)
Radiation Therapy
EXPERIMENTALThese 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.
Interventions
Patients will receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions).
Eligibility Criteria
You may qualify if:
- 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
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk - Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean McBride, MD, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2024
First Posted
July 3, 2024
Study Start
June 27, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
February 4, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
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.