Study on Radiation Therapy After Surgery for Oral Tongue Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06485778

Provider View

This clinical trial is exploring whether adjusting radiation therapy to avoid the surgical site on the tongue can reduce side effects in patients who have had surgery for oral tongue cancer. The study will also assess if this approach impacts the likelihood of cancer returning and evaluate participants' quality of life through questionnaires.

Patient Parameters

Program Overview

The purpose of this study is to determine if changing the standard radiation treatment to avoid the area where surgery was performed on the tongue can help reduce side effects for patients with oral tongue cancer. Researchers will also examine if this method affects the chances of the cancer coming back and will gather information on participants' quality of life by asking them to fill out questionnaires.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have had surgery to remove all visible cancer, with no remaining disease seen on a PET/CT scan.
  • Diagnosed with specific stages (pT1-2, pN0-2b) of squamous cell carcinoma of the oral tongue, confirmed by final surgical pathology.
  • Must have at least two of the following risk features:
    • Lymphovascular invasion (LVI)
    • Depth of invasion (DOI) of 4mm or more
    • 1 or 2 small cancerous lymph nodes (N1 to low volume N2b)
  • Surgical margins of the primary specimen must be 3mm or more.
  • Must sign an informed consent form, either personally or through a legally authorized representative.

Exclusion Criteria

  • Have more advanced nodal disease (N2c/N3).
  • Have more than 2 cancerous lymph nodes.
  • Surgical margins of the primary specimen less than 3mm.
  • Presence of perineural invasion (PNI).
  • Cancer spread beyond the lymph node capsule.
  • Surgery performed at a different institution, unless approved by the principal investigator.
  • Have another invasive cancer that poses a similar risk of death as the oral tongue cancer, according to the principal investigator.
  • Have autoimmune conditions that would prevent radiation treatment, as determined by the principal investigator (e.g., scleroderma).
  • Unable to understand or unwilling to sign a written consent form and complete questionnaires.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.