Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07121595

Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial

Led by University of Michigan Rogel Cancer Center · Updated on 2025-08-13

50

Participants Needed

1

Research Sites

258 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase II trial studies how well personalized neck radiation therapy directed by sentinel lymph node biopsy (SLNB) works in treating patients with oral cavity squamous cell carcinoma (OCSCC). SLNB can be performed as part of standard care for OCSCC. During SLNB, a radiotracer is injected around the tumor. The lymph nodes are then biopsied and tested to see if the tracer injected into the tumor traveled to and is present in the sentinel lymph nodes (SLNs). Results of the SLNB are used to determine whether lymph nodes should be removed in both sides of the neck or just on the same side as the primary tumor. Standard treatment then involves radiation therapy to both sides of the neck, regardless of SLNB results. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Studies have shown only a small number of patients develop a return of the cancer (recurrence) in the opposite side of the neck after radiation therapy. In addition, radiation therapy can negatively impact patient outcomes like saliva production, speech and swallow function, increased risk of radiation induced cancers, and chronic pain. Standard of care SLNBs may be effective in determining whether radiation therapy only needs to be administered to one side of the neck or both sides. This may help spare tissue on the opposite side of the neck from receiving radiation if there is no indication of lymph node involvement there.

CONDITIONS

Official Title

Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy-proven squamous cell carcinoma of the oral cavity
  • Clinical stage cT1-4a N0-2b M0 within 42 days of enrollment confirmed by history, physical exam, and imaging
  • Documentation of lateralized primary tumor site
  • Cross-sectional imaging of head, neck, and chest within 42 days of enrollment
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 within 42 days of enrollment
  • Age over 18 years
  • Recommended treatment plan includes surgical resection with ipsilateral neck dissection and SPECT-CT-guided sentinel node biopsy
  • Willing and able to provide informed consent
  • Women of childbearing potential and male participants agree to use effective birth control during treatment phase
Not Eligible

You will not qualify if you...

  • Evidence of distant metastatic disease by clinical or radiologic evaluation
  • Evidence of contralateral neck disease on staging imaging
  • Prior non-head and neck invasive malignancy unless disease free for at least 2 years (except certain skin cancers and carcinoma in situ of breast or cervix)
  • Diagnosis of squamous cell carcinoma in oropharynx, nasopharynx, hypopharynx, or larynx
  • Prior systemic chemotherapy for this cancer (prior chemotherapy for other cancers allowed)
  • Prior radiotherapy overlapping study cancer region
  • Severe active co-morbidity preventing elective or completion neck dissection
  • Pregnancy or breastfeeding
  • Excisional biopsy for study cancer
  • Prior surgery involving lateral neck that prevents surgical dissection (thyroid and central neck surgery allowed; incisional biopsy permitted)
  • History of hematologic malignancy or active disease causing lymphadenopathy
  • Currently receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte, or immunomodulatory therapy
  • Participation in another investigational therapeutic trial

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

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Research Team

C

Cancer AnswerLine

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial | DecenTrialz