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

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

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of California, Davis

About this trial

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 criteria

Qualifiers

Must have histologically and/or biochemically confirmed head and neck cSCC

Location in the ear or the lip,

Diameter greater than 2 cm,

Depth greater than 4 mm,

Disqualifiers

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.

Trial design

Treatments tested in this trial

Sentinel lymph node biopsy (SLNB)
Lymphadenectomy
Adjuvant Definitive Therapy

Treatment groups

24 Participants

are divided into 1 treatment group

Sponsors and collaborators

University of California, Davis

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov