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RECRUITING

NCT06990737

PHASE2

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

Sponsor: University of California, Davis

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06-25

Completion Date

2032-08-01

Last Updated

2025-07-15

Healthy Volunteers

Conditions

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

Interventions

PROCEDURE

Sentinel lymph node biopsy (SLNB)

Participants will have SLNs excised from the affected area(s) per standard of care

PROCEDURE

Lymphadenectomy

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.

DRUG

Adjuvant 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

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. Age ≥18 years at time of consent. 7. Provision of signed and dated informed consent form. 8. Stated willingness to comply with all study procedures and availability for the duration of the study. Exclusion Criteria: 1. Other active cancers. 2. Definitive clinical or radiologic evidence of regional (cervical) and/or distant metastatic disease. 3. 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. 4. Diagnosis of head and neck mucosal SCC. 5. Prior systemic chemotherapy for head and neck mucosal SCC; note that prior chemotherapy for a different cancer is allowable. 6. Prior radiotherapy to the head and neck that would result in overlap of radiation therapy fields. 7. Patient with severe, active co-morbidity that would preclude a lymphadenectomy. 8. Pregnant or breast-feeding persons. 9. 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. 10. 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). 11. Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte, or immunomodulatory therapy. 12. Currently participating in another investigational therapeutic trial.

Locations (1)

University of California, Davis

Sacramento, California, United States