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RECRUITING
NCT07121595
PHASE2

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

Sponsor: University of Michigan Rogel Cancer Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-07-17

Completion Date

2030-07-01

Last Updated

2025-08-13

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT and/or SPECT-CT

PROCEDURE

Modified Barium Swallow

Undergo video fluoroscopic swallow study

DRUG

Paclitaxel

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET-CT

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Radiation Therapy

Undergo RT

PROCEDURE

Sentinel Lymph Node Biopsy

Undergo SLNB

PROCEDURE

Single Photon Emission Computed Tomography

Undergo SPECT-CT

RADIATION

Technetium Tc 99m-labeled Tilmanocept

Given via injection

OTHER

Technetium Tc-99m Sulfur Colloid

Given via injection

Locations (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States