NCT07121595

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-07-17
• Primary completion: 2030-07-01
• Completion: 2030-07-01
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study