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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT06990737
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sentinel lymph node biopsy (SLNB) — PROCEDURE
    Participants will have SLNs excised from the affected area(s) per standard of care
  • 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.
  • 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

Study Details

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 Dates

Start date
Jun 25, 2025
Status verified
Jul 2025
Primary completion
Aug 1, 2031
Completion
Aug 1, 2032

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sentinel lymph node biopsy (SLNB) + Lymphadenectomy + Adjuvant Definitive Therapy
    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.

Primary Outcome Measure

Disease-free survival (DFS) [ Time Frame: Up to 2 years post definitive therapy completion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, DavisSacramentoCalifornia95817
Selina Laqui
[email protected]
916-734-0565

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By research site
University of California, Davis· Sacramento, CA

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