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

Recruiting now · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT06990737

Run by

University of California, Davis

People needed

24

Starts

2025-06-25

Expected to finish

2032-08-01

Last updated by the study team

2025-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have histologically and/or biochemically confirmed head and neck cSCC
• Must have head and neck cSCC categorized as high risk:
• Location in the ear or the lip,
• Diameter greater than 2 cm,
• Depth greater than 4 mm,
• Perineural invasion,
• Poorly differentiated, and/or
• Recurrent disease
• Lymph-node negative (cN0) status confirmed by computed tomography (CT) imaging.
• Candidate for surgical intervention with sentinel lymph node biopsy (SLNB) and potential lymphadenectomy for treatment of cSCC.
• Zubrod Performance Status 0-2
• Age ≥18 years at time of consent.
• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.

You may not qualify if…

• Other active cancers.
• Definitive clinical or radiologic evidence of regional (cervical) and/or distant metastatic disease.
• Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer, including effectively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix) unless disease free for ≥ 2 years.
• Diagnosis of head and neck mucosal SCC.
• Prior systemic chemotherapy for head and neck mucosal SCC; note that prior chemotherapy for a different cancer is allowable.
• Prior radiotherapy to the head and neck that would result in overlap of radiation therapy fields.
• Patient with severe, active co-morbidity that would preclude a lymphadenectomy.
• Pregnant or breast-feeding persons.
• Prior surgery involving the lateral neck, including neck dissection or gross injury to the neck that would preclude surgical dissection for this trial. Prior thyroid and central neck surgery is permissible; biopsy is permitted. Prior surgery for confirmation of tumor pathology is permitted. Note: Borderline suspicious nodes that are ≥1 cm with radiographic finding suggestive of NOT malignant should be biopsied using U/S-guided fine-needle aspirate (FNA) biopsy.
• Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic leukemia) or other active disease capable of causing lymphadenopathy (sarcoidosis or untreated mycobacterial infection).
• Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte, or immunomodulatory therapy.
• Currently participating in another investigational therapeutic trial.

Where it is running

• University of California, Davis — Sacramento, California, United States (enrolling)

Full record on ClinicalTrials.gov

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