Actively Recruiting
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
Led by University of California, Davis · Updated on 2025-07-15
24
Participants Needed
1
Research Sites
370 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or biochemically confirmed cutaneous squamous cell carcinoma of the head and neck
- Tumor classified as high risk due to location (ear or lip), size over 2 cm, depth over 4 mm, perineural invasion, poor differentiation, or recurrence
- Clinically node-negative (cN0) status confirmed by CT imaging
- Candidate for surgical treatment including sentinel lymph node biopsy and possible lymphadenectomy
- Zubrod Performance Status between 0 and 2
- Age 18 years or older at consent
- Signed informed consent provided
- Willingness and availability to comply with study procedures throughout the study period
You will not qualify if you...
- Presence of other active cancers
- Clinical or radiologic evidence of regional or distant metastatic disease
- Prior invasive non-head and neck malignancy within 2 years except certain non-melanoma skin cancers or carcinoma in situ
- Diagnosis of head and neck mucosal squamous cell carcinoma
- Prior systemic chemotherapy for head and neck mucosal squamous cell carcinoma
- Prior overlapping radiotherapy to the head and neck
- Severe active co-morbidities preventing lymphadenectomy
- Pregnancy or breastfeeding
- Prior surgery involving the lateral neck that precludes surgical dissection
- History of hematologic malignancy or diseases causing lymphadenopathy
- Current use of systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte, or immunomodulatory therapy
- Participation in another investigational therapeutic trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
S
Selina Laqui
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here