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
University of California, Davis
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Must have histologically and/or biochemically confirmed head and neck cSCC 2. Must have head and neck cSCC categorized as high risk: 1. Location in the ear or the lip, 2. Diameter greater than 2 cm, 3. Depth greater than 4 mm, 4. Perineural invasion, 5. Poorly differentiated, and/or 6. Recurrent disease 3. Lymph-node negative (cN0) status confirmed by computed tomography (CT) imaging. 4. Candidate for surgical intervention with sentinel lymph node biopsy (SLNB) and potential lymphadenectomy for treatment of cSCC. 5. Zubrod Performance Status 0-2 6. Ag…
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
Location
- University of California, DavisSacramento, California