The SNIC trial assesses the value of Sentinel Node Biopsy for high risk cutaneous squamous cell carcinoma (SCC). Most cutaneous SCCs do not metastasize to lymph nodes – the rate overall is approximately 5%. However, some have a much higher risk (20%) when certain clinicopathological features are present (see below). When metastases occur, patients are usually treated with radical surgery and radiotherapy. Both the advanced disease stage and the treatment in that case often lead to substantial morbidity.
Sentinel lymph node biopsy, which is commonly used in melanoma and breast cancer to improve nodal staging may allow earlier identification of metastases in patients with high-risk SCC lesions. Early identification of sub-clinical metastases from high-risk SCC may lead to early treatment and thereby an increase in survival and improved quality of life.
The SNIC trial is a randomised multi-centre trial where participants will be allocated to either standard watch and wait management, or a sentinel lymph node biopsy procedure. If pathology results reveal evidence of metastatic disease they will receive clearance (or radiotherapy) of the lymph node regions in the area. All patients will undergo routine follow up.
The first phase of the SNIC trial is underway and is a non-randomised single arm pilot study aimed to:
1) Assess feasibility of sentinel node biopsy for cutaneous SCC and accrual rates
2) Validate ‘high risk’ clinicopathological features considered to increase the risk of lymph node metastases
3) Assess morbidity of sentinel node biopsy
The pilot study commenced in July 2010 and is estimated to run for 18 – 24 months. The next phase of the SNIC trial will be a prospective randomised multi-centre trial. The RCT will proceed if accrual in phase I/II is adequate and morbidity is low.
1) Who is suitable for the study (inclusion criteria)?
Patients who have any of the following characteristics of the primary lesion may be suitable for participation. These high-risk features have been identified through other studies, and are included in the criteria for upstaging lesions in the new TNM staging system for non melanoma skin cancer.
Location of lesion on ear or lip
Carcinoma in pre-existing scar
Any SCC in an immunocompromised patient (post-organ transplant, chemotherapy)
Primary size > 2cm
Invasion into subcutaneous fat, or tumour thickness >5 mm
Incomplete resection margins
Poorly differentiated, or histological characteristics like basosquamous, desmoplastic, metatypical or morpheophorm phenotype
To participate patients should be willing and able to complete 2 – 5 years of follow up. Patients may have had their primary lesion excised already, or have this treated by another specialist such as their dermatologist or plastic surgeon, then referred on to study investigators for the sentinel lymph node biopsy procedure.
2) Who is not suitable for the study (exclusion criteria)?
Patients with any of the following will not be eligible for participation in the trial:
– Clinical evidence of distant metastases.
– Allergy to blue dye or radio-colloid used for sentinel lymph node biopsy procedure
– Pregnant or lactating.
– Significant cognitive or psychiatric disorder that make them unable to understand informed consent.
3) How do I enroll a patient in the study?
If you have a patient who may be suitable for the trial, then please fill in the Case Record Form, and fax or email to the Sydney Head and Neck Cancer Institute + 61 2 9515 7483 or firstname.lastname@example.org. Received forms will be forwarded to Dr Jonathan Clark, chief investigator for this trial. Alternatively, email email@example.com and we will contact you to discuss eligibility (please provide contact details).
4) How do I get more information about the study?
This trial has received approval by the Ethics Review Committee of SSWAHS – RPA Zone (HREC X09-0325). Centres currently approved for participation include:
– Royal Prince Alfred Hospital
RPA Patient Consent SNIC Trial
RPA Patient Information SNIC Trial
– Concord Repatriation Hospital
– Liverpool Hospital
Liverpool Patient Consent SNIC Trial
Liverpool Patient Information SNIC Trial
– Wollongong Hospital
– Strathfield Private Hospital
If you would like more information on this trial, please send correspondence to firstname.lastname@example.org.