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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a procedure called Sentinel Lymph Node Biopsy (SLNB) to determine its effectiveness for individuals with high-risk cutaneous squamous cell carcinoma (cSCC) in the head and neck. Researchers aim to assess whether this biopsy, combined with other treatments, improves disease-free survival two years post-treatment. It is most suitable for those with high-risk cSCC featuring tumors larger than 2 cm or located in the ear or lip, without cancer spread to the lymph nodes. Participants must be prepared for surgery and follow-up treatments as part of the study. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are actively receiving certain treatments like systemic chemotherapy or immunosuppressive therapy, you may not be eligible to participate.

What prior data suggests that this technique is safe for patients with high-risk cSCC?

Research has shown that Sentinel Lymph Node Biopsy (SLNB) is generally safe. Studies have found that SLNB works well and remains safe for patients, even those with previous tumor removals or recurrences. It helps detect small cancer spread when there are no clear signs of cancer in the lymph nodes. Most research concludes that SLNB is well-tolerated and carries a low risk of complications. These findings suggest that SLNB is a reliable and safe option for patients with squamous cell carcinoma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Sentinel Lymph Node Biopsy (SLNB) for squamous cell carcinoma because it offers a more precise way to determine the spread of cancer without unnecessarily removing lymph nodes. Unlike traditional approaches that might involve removing many lymph nodes, SLNB targets just the sentinel nodes—the first nodes to which cancer would likely spread. This can reduce complications and recovery time compared to more extensive surgeries. Additionally, combining SLNB with lymphadenectomy and definitive systemic therapy, such as radiation or chemoradiation, provides a comprehensive approach to treatment, potentially improving outcomes for patients.

What evidence suggests that Sentinel Lymph Node Biopsy is effective for high-risk squamous cell carcinoma?

Research has shown that Sentinel Lymph Node Biopsy (SLNB), which participants in this trial will undergo, is a safe and effective method for identifying lymph nodes affected by squamous cell carcinoma, a type of skin cancer. One review found that SLNB detected cancer in 13.5% of selected patients. Another study found cancer in 24.6% of removed lymph nodes, highlighting its reliability in spotting cancer spread. SLNB is minimally invasive, requiring no large cuts, and helps accurately determine the stage of cancer. These findings suggest that SLNB could benefit patients with high-risk squamous cell carcinoma. ^{2 3 5 6 7}

Who Is on the Research Team?

Andrew Birkeland, MD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

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 radiation to my head or neck that overlaps with new treatment areas.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10969103/

Sentinel Lymph Node Biopsy (SLNB) for Early-Stage Head ...

Results revealed 24.6% SLN biopsy positivity, with 169 SLNs resected and a 21.9% positivity ratio. The study suggests SLNB's reliability for T1- ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1368837525004270

Sentinel lymph node biopsy in early-stage oral squamous ...

This study examines lymphatic drainage patterns and clinical outcomes in pT1/T2 OSCC patients undergoing SLNB while establishing optimal thresholds for SLN ...

3.

jamanetwork.com

jamanetwork.com/journals/jamadermatology/fullarticle/1774052

Staging for Cutaneous Squamous Cell Carcinoma as a ...

Sentinel lymph node biopsy has been shown to be safe, minimally invasive, and effective in identifying SLNs in patients with cSCC. In a systematic review of the ...

4.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.21.02781

Should Sentinel Lymph Node Biopsy Be Considered the ...

The French study used 2-year neck node recurrence-free survival as primary end point with noninferiority margin of 10% (upper bound of 2-year ...

5.

emedicine.medscape.com

emedicine.medscape.com/article/854550-overview

Sentinel Lymph Node Biopsy for Squamous Cell Carcinoma

Data from a systematic review show a positive SLN rate of 13.5% in patients carefully selected for the procedure. A 5-year retrospective case ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11853356/

Is the Sentinel Lymph Node Biopsy Safe and Accurate After ...

Conclusions: SLNB is a feasible and safe option in patients who have had previous excision of the vulvar tumor and in patients with a recurrence ...

7.

mdpi.com

mdpi.com/2072-6694/16/24/4279

Sentinel Lymph Node Biopsy: Is There a Role in Non- ...

We found an SLNB positivity rate of 24.4%, with an SNLB detection rate of 97.6%. Most papers concluded that the SLNB is safe, feasible, and significant in these ...