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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT07121595
Phase
PHASE2
Status
Recruiting
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Conditions

  • Oral Cavity Squamous Cell Carcinoma
  • Stage I Lip and Oral Cavity Cancer AJCC v8
  • Stage II Lip and Oral Cavity Cancer AJCC v8
  • Stage III Lip and Oral Cavity Cancer AJCC v8
  • Stage IVA Lip and Oral Cavity Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Carboplatin — DRUG
    Given IV
  • Cisplatin — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT and/or SPECT-CT
  • Modified Barium Swallow — PROCEDURE
    Undergo video fluoroscopic swallow study
  • Paclitaxel — DRUG
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET-CT
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Radiation Therapy — RADIATION
    Undergo RT
  • Sentinel Lymph Node Biopsy — PROCEDURE
    Undergo SLNB
  • Single Photon Emission Computed Tomography — PROCEDURE
    Undergo SPECT-CT
  • Technetium Tc 99m-labeled Tilmanocept — RADIATION
    Given via injection
  • Technetium Tc-99m Sulfur Colloid — OTHER
    Given via injection

Study Details

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.

Key Dates

Start date
Jul 17, 2025
Status verified
Aug 2025
Primary completion
Jul 1, 2030
Completion
Jul 1, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (SLN mapping, SLNB, RT, chemotherapy)
    See Detailed Description.

Primary Outcome Measure

Contralateral regional control rate [ Time Frame: From completion of definitive treatment to neck recurrence date, death date or date of last contact, assessed at 1 year from completion of definitive treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109
Cancer AnswerLine
[email protected]
800-865-1125
Jennifer L. Shah (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan Comprehensive Cancer Center· Ann Arbor, MI

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