Phase 2 Pragmatic Trial of Sentinel Lymph Node Biopsy (SLNB) in Patients With Clinically Node-Negative (cN0), High-Risk Cutaneous Squamous Cell Carcinoma (cSCC) of the Head and Neck

PHASE2RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 25, 2025

Primary Completion Date

August 1, 2031

Study Completion Date

August 1, 2032

Conditions
Cutaneous Squamous Cell Carcinoma of the Head and NeckClinically Node-Negative (cN0)High-Risk Cutaneous Squamous Cell Carcinoma (cSCC) of the Head and Neck
Interventions
PROCEDURE

Sentinel lymph node biopsy (SLNB)

Participants will have SLNs excised from the affected area(s) per standard of care

PROCEDURE

Lymphadenectomy

Surgeon preference will dictate the order of the surgery for resecting the primary tumor. Elective neck dissection (END) will include nodal basins based on the primary site of disease, at-risk nodal basins, and any additional dissection per the surgeon's discretion. In the event of a positive SLN, the completion neck dissection (CND) should be completed.

DRUG

Adjuvant Definitive Therapy

Use of chemotherapy will depend on the specific phase of treatment and high-risk features as per standard of care and NCCN Head and Neck Cancer-Clinical Practice Guidelines in Oncology

Trial Locations (1)

95817

RECRUITING

University of California, Davis, Sacramento

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

University of California, Davis

OTHER