NCT07121595View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

July 17, 2025

Primary Completion Date

July 1, 2030

Study Completion Date

July 1, 2030

Conditions
Oral Cavity Squamous Cell CarcinomaStage I Lip and Oral Cavity Cancer AJCC v8Stage II Lip and Oral Cavity Cancer AJCC v8Stage III Lip and Oral Cavity Cancer AJCC v8Stage 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

Trial Locations (1)

48109

RECRUITING

University of Michigan Comprehensive Cancer Center, Ann Arbor

All Listed Sponsors
lead

University of Michigan Rogel Cancer Center

OTHER

NCT07121595 - Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial | Biotech Hunter | Biotech Hunter