NCT06990737 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
| NCT ID | NCT06990737 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, Davis |
| Condition | Cutaneous Squamous Cell Carcinoma of the Head and Neck |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-06-25 |
| Primary Completion | 2031-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2025-06-25 with a primary completion date of 2031-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Andrew Birkeland, MD
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT06990737 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cutaneous Squamous Cell Carcinoma of the Head and Neck. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06990737 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06990737 currently recruiting?
Yes, NCT06990737 is actively recruiting participants. Contact the research team at sblaqui@ucdavis.edu for enrollment information.
Where is the NCT06990737 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT06990737 clinical trial?
NCT06990737 is sponsored by University of California, Davis. The principal investigator is Andrew Birkeland, MD at University of California, Davis. The trial plans to enroll 24 participants.