RecruitingPhase 2NCT06990737

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

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

Sponsor

University of California, Davis

Enrollment

24 participants

Start Date

Jun 25, 2025

Study Type

INTERVENTIONAL

Conditions

Cutaneous Squamous Cell Carcinoma of the Head and Neck Clinically Node-Negative (cN0)High-Risk Cutaneous Squamous Cell Carcinoma (cSCC) of the Head and Neck

Summary

This is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of SLNB in patients with high-risk cSCC and cN0. The primary goal is to evaluate the efficacy of SLNB based on the DFS rate at 2 years post-definitive therapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a procedure called sentinel lymph node biopsy — which maps and samples the first lymph node a cancer might spread to — can accurately detect cancer spread in patients with high-risk squamous cell skin cancer of the head and neck. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of squamous cell skin cancer (not mucosal) on the head or neck - Your cancer is considered high risk (large size, deep invasion, nerve involvement, or recurrent disease) - There is no confirmed cancer in your lymph nodes on CT scan - You are a surgical candidate **You may NOT be eligible if...** - You have another active cancer - You have confirmed spread to lymph nodes or distant sites - You have had prior radiation to the head and neck that would overlap treatment areas - You are pregnant or breastfeeding - You have had prior surgery to the lateral neck that would prevent proper dissection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURESentinel lymph node biopsy (SLNB)

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

PROCEDURELymphadenectomy

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.

DRUGAdjuvant 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