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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan Rogel Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

Patient must have biopsy-proven squamous cell carcinoma of the oral cavity

History and physical examination within 42 days of study enrollment; must include documentation of lateralized primary tumor site

Cross-sectional imaging of the head and neck within 42 days of study enrollment

Cross-sectional imaging of the chest within 42 days of study enrollment

Disqualifiers

Evidence of distant metastatic disease based on clinical or radiologic evaluation

Evidence of contralateral neck disease on staging imaging

Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer, including effectively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix) unless disease free for ≥ 2 years

Diagnosis of head and neck squamous cell carcinoma (SCC) in the oropharynx, nasopharynx, hypopharynx, and larynx

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Carboplatin
  • Cisplatin
  • Computed Tomography
  • Modified Barium Swallow
  • Paclitaxel
  • Positron Emission Tomography
  • Questionnaire Administration
  • Radiation Therapy
  • Sentinel Lymph Node Biopsy
  • Single Photon Emission Computed Tomography
  • Technetium Tc 99m-labeled Tilmanocept
  • Technetium Tc-99m Sulfur Colloid

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

1
University of Michigan Comprehensive Cancer Center48109, Ann ArborMichigan, United States

Sponsors and collaborators

University of Michigan Rogel Cancer Center

Lead sponsor