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

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.

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

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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center

  lead OTHER

Principal Investigators

• Jennifer L Shah · University of Michigan Rogel Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-17

Primary Completion

2030-07-01

Completion

2030-07-01

FDA Drug

Yes

Countries

• United States

Study Locations