RECRUITING

A Study of Radiation Therapy After Surgery in People With Oral Tongue Squamous Cell Carcinoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 2 Single Arm Trial of Adjuvant Nodal Irradiation Alone in Post Operative Oral Tongue Squamous Cell Carcinoma

Quick Facts

Study Start:2024-06-27
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06485778

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18
  2. * Surgical resection of all gross disease without evidence of residual loco-regional disease on simulation PET/CT.
  3. * pT1-2,pN0-2b Squamous Cell Carcinoma of the Oral Tongue confirmed on final surgical pathology. Patients must have:
  4. * at least two of the following pathologic risk features
  5. * LVI
  6. * DOI ≥ 4mm OR
  7. * 1 or 2 pathologically positive nodes N1 to low volume N2b.
  8. * Primary specimen surgical margins ≥3 mm
  9. * Signed informed consent form by the participant or their legally authorized representative (LAR)
  1. * N2c/N3 nodal disease
  2. * \>2 pathologically positive nodes
  3. * Primary specimen surgical margin \< 3 mm
  4. * Perineural Invasion (PNI)
  5. * Extra-capsular extension in any pathologically positive lymph node
  6. * Surgery at outside institution (PI can give approval for patients operating on outside)
  7. * 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.
  8. * Auto-immune conditions that would otherwise preclude radiation in the opinion of the PI (e.g. Scleroderma).
  9. * Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.

Contacts and Locations

Study Contact

Sean McBride, MD, PhD
CONTACT
646-608-2450
mcbrides@mskcc.org
Nancy Lee, MD
CONTACT
212-639-3341

Principal Investigator

Sean McBride, MD, PhD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Sean McBride, MD, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-27
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-06-27
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • pT1-2,pN0-2b
  • intensity modulated radiation therapy (IMRT)
  • 24-167

Additional Relevant MeSH Terms

  • Oral Tongue Squamous Cell Carcinoma