Sentinel Lymph Node Biopsy for Squamous Cell Carcinoma

Overseen By Selina Laqui

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Davis

Must not be taking: Cytotoxic chemotherapy, Immunosuppressive therapy

Disqualifiers: Other active cancers, Metastatic disease, Hematologic malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Andrew Birkeland, MD

Principal Investigator

University of California, Davis

Eligibility Criteria

This trial is for adults with high-risk cutaneous Squamous Cell Carcinoma (cSCC) of the head and neck, who have no lymph node involvement confirmed by CT scan. Participants must be able to undergo surgery, provide consent, and commit to study procedures. Exclusions include prior treatments that overlap with the study's scope, other active cancers, pregnancy or breastfeeding, certain past surgeries or conditions affecting lymph nodes.

Inclusion Criteria

My CT scans show no cancer in my lymph nodes.

I am eligible for surgery to check and possibly remove lymph nodes due to my skin cancer.

I am 18 years old or older.

Exclusion Criteria

I have been diagnosed with squamous cell carcinoma in the head or neck area.

I have a serious health condition that prevents me from having lymph node surgery.

I've had chemotherapy for head and neck cancer but not for other cancers.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Lymphoscintigraphy

Participants undergo preoperative lymphoscintigraphy before planned surgery

1 week

Surgery

Participants undergo sentinel lymph node biopsy and potential lymphadenectomy

1 week

1 visit (in-person)

Definitive Systemic Therapy

Participants receive radiation therapy or chemoradiation therapy following surgery

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Treatment Details

Interventions

• Sentinel Lymph Node Biopsy (SLNB)

Trial Overview The trial tests Sentinel Lymph Node Biopsy (SLNB) effectiveness in patients with cSCC of the head and neck without clinical signs of lymph node spread. It aims to determine if SLNB can accurately guide adjuvant therapy decisions by measuring disease-free survival rates two years after definitive treatment.

Participant Groups

Group I: Sentinel lymph node biopsy (SLNB) + Lymphadenectomy + Adjuvant Definitive Therapy Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+