NCT06990737

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Participants must be a candidate for surgical intervention with sentinel lymph node biopsy (SLNB) and potential lymphadenectomy for treatment of cSCC. Following enrollment, participants will have preoperative lymphoscintigraphy performed before planned surgery. During surgery, participants will have SLNs excised from the affected area(s) per standard of care. Surgeon preference will dictate the order of the surgery for resecting the primary tumor. The surgeon may elect to return to the operating room for re-resection of the primary tumor to achieve a negative pathological margin. This may also coincide with a lymphadenectomy if the patient has a positive SLN. Participants will be monitored for adverse events (AEs) during and following their SLNB per institutional practices; only pre-specified AEs of interest will be documented for the study. Definitive systemic therapy (e.g., radiation therapy, chemoradiation therapy) will then be administered per standard of care following surgery. The primary aim is to evaluate the efficacy of SLNB based on the disease-free survival (DFS) rate at 2 years post-definitive therapy compared to historical control. The patients' 2-year DFS will be analyzed using the Kaplan-Meier approach, and a one-sided log-rank test will be conducted to compare the DFS based on the historical control (50%). Secondary aims include surgical and perioperative morbidity evaluations, and efficacy evaluations assessed by 2-year local/regional control rate, 2-year overall survival, and sensitivity/ specificity of for occult nodal disease.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-06-25
• Primary completion: 2031-08-01
• Completion: 2032-08-01
• First posted: 2025-05-25
• Last updated: 2025-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study