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

NCT06990737 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: UCDCC319
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  Defined as the time from definitive therapy to local/regional relapse, distant metastasis, or death due to any cause, whichever comes first.

  Up to 2 years post definitive therapy completion

Secondary Outcomes (5)

• Number of participants experiencing surgical and perioperative morbidity

  Through 30 days post-sentinel lymph node biopsy

• Local/regional control

  Up to 2 years post definitive therapy completion

• Overall survival

  Up to 2 years post definitive therapy completion

• Sensitivity of sentinel lymph node biopsy for occult nodal disease

  Up to 14 days post-SLNB

• Specificity of sentinel lymph node biopsy for occult nodal disease

  Up to 14-days post-SLNB

Study Arms (1)

Sentinel lymph node biopsy (SLNB) + Lymphadenectomy + Adjuvant Definitive Therapy

EXPERIMENTAL

Participants will have SLNs excised from the affected area(s) per standard of care. Surgeon preference will dictate the order of the surgery for resecting the primary tumor. This may also coincide with a lymphadenectomy if the patient has a positive SLN. Definitive systemic therapy (e.g., radiation therapy, chemoradiation therapy) will then be administered per standard of care following surgery.

Procedure: Sentinel lymph node biopsy (SLNB); Procedure: Lymphadenectomy; Drug: Adjuvant Definitive Therapy

Interventions

Sentinel lymph node biopsy (SLNB) PROCEDURE

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

Sentinel lymph node biopsy (SLNB) + Lymphadenectomy + Adjuvant Definitive Therapy

Lymphadenectomy PROCEDURE

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.

Sentinel lymph node biopsy (SLNB) + Lymphadenectomy + Adjuvant Definitive Therapy

Adjuvant Definitive Therapy DRUG

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

Sentinel lymph node biopsy (SLNB) + Lymphadenectomy + Adjuvant Definitive Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Interventions

Sentinel Lymph Node Biopsy; Lymph Node Excision

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Andrew Birkeland, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Selina Laqui

CONTACT

916-734-0565; sblaqui@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): August 1, 2031
• Study Completion (Estimated): August 1, 2032
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)