Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05108090 |
| Other study ID # |
CTO-OTHN-IUSCC-0741 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 25, 2021 |
| Est. completion date |
September 2024 |
Study information
| Verified date |
July 2023 |
| Source |
Indiana University |
| Contact |
Azeezat Yekinni |
| Phone |
317-529-6883 |
| Email |
ayekinn[@]iu.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to research if a type of biopsy known as sentinel lymph node
biopsy (SLNB) can help in determining the rate of tumor deposits that are hard to detect and
identify in node-negative cutaneous squamous cell carcinoma of the head or neck.
Description:
Nonmelanoma skin cancer is the most commonly diagnosed malignancy in the United States, with
cutaneous squamous cell carcinoma (cSCC) representing about 20% of those cases. It is
estimated that there are 700,000 patients diagnosed each year in the United States and the
incidence has been increasing worldwide. Most tumors are found within the sun-exposed areas
of the head and neck. The vast majority require only local treatment, however there is a
subset of patients who present with regionally metastatic disease. Retrospective reviews have
determined factors associated with recurrence, metastasis, and disease-specific death include
tumor size ≥ 2 cm, location on lip and ear, perineural and lymphovascular invasion, poorly
differentiated histology, tumor extension beyond fat and immunosuppressed patients.
There have been multiple proposed staging schemes, including the American Joint Committee on
Cancer (AJCC) and recently the Brigham and Women's Hospital (BWH) tumor staging. AJCC staging
utilizes the size for early stage tumors, T1 < 2 cm and T2 ≥ 2 cm and less than 4 cm.
Advanced tumors, T3 and T4 are stratified by aggressive features, including invasion beyond
fat, perineural invasion (PNI), or bone/skull base erosion. BWH aimed to better stratify
tumors by the number of aggressive features, T1 tumors with 0 features, T2a tumors with 1
feature, T2b with 2-3 features, and T3 with 4 or more features. High-risk features include
tumor diameter ≥ 2 cm, poorly differentiated histology, PNI, tumor invasion beyond fat, or
bone erosion. In a recent study, and found BWH provided superior prognostication for patients
with localized cSCC as compared to AJCC7. However, BWH does not address regional or distant
metastasis and therefore current treatment guidelines are based on BWH staging scheme. AAJCC
systemCurrently, there is a general paucity of prospective data that can provide a consensus
on risk-stratification of cutaneous squamous cell carcinomas and subsequent treatment
algorithm. A consensus on risk-stratification for high-risk cSCC is lacking; consequently,
treatment algorithm for primary tumors and nodal disease is not clear.
There is a subset of tumors with increased risk of local recurrence, nodal and distant
metastasis which has yet to be elucidated. Data has shown metastasis to regional lymph nodes
is the strongest predictor of recurrence and survival, and risk of nodal metastasis is noted
to be 6% for all-comers and upwards of 20% for high-risk tumors. Therefore, detecting
subclinical metastatic disease is extremely important for staging aggressive skin cancers and
optimizing treatment.Imaging, including CT, MRI and PET, are considered for high-risk tumor.
Data has demonstrated a higher risk of developing local recurrence, nodal metastasis and
death from disease in patients that did not receive pre-treatment imaging as compared those
who underwent imaging.
Guidelines recommend surgical excision of the primary tumor as first line treatment for
cutaneous squamous cell carcinoma. Both Moh's micrographic surgery (MMS) and standard
excision are both considered feasible surgical options. Available literature on management of
lymph node metastasis largely limited to retrospective reviews and case series. Therefore,
optimal management of regional lymph nodes for high-risk tumors remains unclear.
Sentinel lymph node biopsy (SNLB) is a common procedure utilized in multiple oncologic
surgeries, especially dermatology. SLNB is recommended for aggressive skin cancers including
melanoma and Merkel cell carcinoma. There is limited data on the utility of SLNB in
nonmelanoma skin cancers, including cutaneous SCC. To date, there have been no prospective
trials and current data comes from small retrospective studies. Therefore, the impact of SLNB
on management and outcomes with high-risk cSCC remains unknown. Therefore, the impact of SLNB
on cSCC remains unclear. The purpose of this study is to evaluate the rate of occult
metastasis utilizing sentinel lymph node biopsy in clinically node-negative intermediate and
high-risk cSCC.
