Phase 2 Study of Sentinel Lymph Node Biopsy for High-Risk Head and Neck Skin Cancer
This Phase 2 study is looking at how well a procedure called Sentinel Lymph Node Biopsy (SLNB) works for people with a high-risk type of skin cancer on the head and neck, called cutaneous squamous cell carcinoma (cSCC). This cancer has not spread to the lymph nodes yet (clinically node-negative, or cN0). The study will involve removing sentinel lymph nodes (the first lymph nodes where cancer cells might spread) and potentially other lymph nodes (lymphadenectomy), followed by standard cancer treatments like radiation or chemotherapy (Adjuvant Definitive Therapy). The main goal is to see how many people remain disease-free two years after their treatment. You may be able to join if you are 18 or older and have high-risk cSCC of the head and neck, such as cancer in the ear or lip, or if it's larger than 2 cm. The current recruitment status is unclear.
- Study design
- This is a Phase 2 study at a single location, involving 24 participants. It is a pragmatic study, meaning it aims to test the intervention in real-world conditions.
- What's involved
- You would undergo preoperative imaging (lymphoscintigraphy), surgery to remove sentinel lymph nodes and potentially other lymph nodes, and then receive standard cancer treatments. You will be monitored for side effects during and after the SLNB procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to two years after completing their definitive therapy to measure disease-free survival.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Site status isn't published for this study.
Conditions
Study leadership
- Andrew Birkeland, MD · PRINCIPAL_INVESTIGATOR · University of California, Davis
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Disease-free survival (DFS)Up to 2 years post definitive therapy completion
Defined as the time from definitive therapy to local/regional relapse, distant metastasis, or death due to any cause, whichever comes first.