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

Trial details

Who runs it

University of California, Davis

Trial code

NCT06990737

Record updated

2026. augusztus 31.

Original 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. The primary goal is to evaluate the efficacy of SLNB based on the DFS rate at 2 years post-definitive therapy.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: 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; 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; 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; Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte, or immunomodulatory therapy; Other active cancers; Definitive clinical or radiologic evidence of regional (cervical) and/or distant metastatic disease; 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); Diagnosis of head and neck mucosal SCC; Patient with severe, active co-morbidity that would preclude a lymphadenectomy; Pregnant or breast-feeding persons; Currently participating in another investigational therapeutic trial.

ClinicalTrials.gov NCT06990737