MedTrace Logo

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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-07-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Andrew Birkeland, MD · University of California, Davis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-25
Primary Completion
2031-08-01
Completion
2032-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06990737 on ClinicalTrials.gov