RECRUITING

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

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2025-06-25
Study Completion:2032-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06990737

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Must have histologically and/or biochemically confirmed head and neck cSCC
  2. 2. Must have head and neck cSCC categorized as high risk:
  3. 1. Location in the ear or the lip,
  4. 2. Diameter greater than 2 cm,
  5. 3. Depth greater than 4 mm,
  6. 4. Perineural invasion,
  7. 5. Poorly differentiated, and/or
  8. 6. Recurrent disease
  9. 3. Lymph-node negative (cN0) status confirmed by computed tomography (CT) imaging.
  10. 4. Candidate for surgical intervention with sentinel lymph node biopsy (SLNB) and potential lymphadenectomy for treatment of cSCC.
  11. 5. Zubrod Performance Status 0-2
  12. 6. Age ≥18 years at time of consent.
  13. 7. Provision of signed and dated informed consent form.
  14. 8. Stated willingness to comply with all study procedures and availability for the duration of the study.
  1. 1. Other active cancers.
  2. 2. Definitive clinical or radiologic evidence of regional (cervical) and/or distant metastatic disease.
  3. 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. 4. Diagnosis of head and neck mucosal SCC.
  5. 5. Prior systemic chemotherapy for head and neck mucosal SCC; note that prior chemotherapy for a different cancer is allowable.
  6. 6. Prior radiotherapy to the head and neck that would result in overlap of radiation therapy fields.
  7. 7. Patient with severe, active co-morbidity that would preclude a lymphadenectomy.
  8. 8. Pregnant or breast-feeding persons.
  9. 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. 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. 11. Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte, or immunomodulatory therapy.
  12. 12. Currently participating in another investigational therapeutic trial.

Contacts and Locations

Study Contact

Selina Laqui
CONTACT
916-734-0565
sblaqui@ucdavis.edu

Principal Investigator

Andrew Birkeland, MD
PRINCIPAL_INVESTIGATOR
University of California, Davis

Study Locations (Sites)

University of California, Davis
Sacramento, California, 95817
United States

Collaborators and Investigators

Sponsor: University of California, Davis

  • Andrew Birkeland, MD, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-25
Study Completion Date2032-08-01

Study Record Updates

Study Start Date2025-06-25
Study Completion Date2032-08-01

Terms related to this study

Additional Relevant MeSH Terms

  • 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