RecruitingPhase 2NCT07121595

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

PRECEDENT: Pilot Phase II Study of Personalized Radiation to the Contralateral Neck Directed by Sentinel Node Evaluation in Lateralized Oral Cavity Squamous Cell Carcinoma


Sponsor

University of Michigan Rogel Cancer Center

Enrollment

50 participants

Start Date

Jul 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized approach to neck radiation therapy for mouth (oral cavity) cancer, guided by sentinel lymph node biopsy. Instead of treating all lymph nodes in the neck with radiation, only the nodes most likely to contain cancer (identified by the sentinel node biopsy) would be targeted, potentially reducing side effects. The cancer must be early-stage and located clearly on one side of the mouth. **You may be eligible if...** - You have biopsy-confirmed squamous cell carcinoma of the oral cavity (mouth cancer) - Your cancer is clinical stage cT1–4a with limited lymph node involvement (N0–N2b), with no distant spread (M0) - Your tumor is clearly located on one side of the mouth - You have had recent head and neck imaging and chest imaging (within 42 days) - Your performance status allows treatment (ECOG 0–1) **You may NOT be eligible if...** - Your tumor crosses the midline or cannot be clearly lateralized - Your cancer has spread to distant organs - You have had prior head and neck radiation therapy - You are unable to undergo sentinel lymph node biopsy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGCarboplatin

Given IV

DRUGCisplatin

Given IV

PROCEDUREComputed Tomography

Undergo CT and/or SPECT-CT

PROCEDUREModified Barium Swallow

Undergo video fluoroscopic swallow study

DRUGPaclitaxel

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET-CT

OTHERQuestionnaire Administration

Ancillary studies

RADIATIONRadiation Therapy

Undergo RT

PROCEDURESentinel Lymph Node Biopsy

Undergo SLNB

PROCEDURESingle Photon Emission Computed Tomography

Undergo SPECT-CT

RADIATIONTechnetium Tc 99m-labeled Tilmanocept

Given via injection

OTHERTechnetium Tc-99m Sulfur Colloid

Given via injection


Locations(1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

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NCT07121595


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