Squamous Cell Carcinoma of the Anus Clinical Trial
Official title:
R-SeNSAR Feasibility Study: The Role of Sentinel Node Biopsy in Patients With Anal Cancer
The purpose of this study is assess the technical and operational feasibility of a specialised biopsy technique, sentinel lymph node biopsy (SLNB), in patients with anal cancer.
SLNB is based on the premise that lymphatic dissemination from a tumour occurs in a stepwise
fashion, with initial involvement of a primary node, called the sentinel node, before
dissemination to the remainder of the lymphatic chain. If the sentinel node is
histologically negative, then the remainder of the nodes in the same anatomic region will be
at a lower (assumed to be minimal) risk of containing metastases. SLNB is part of standard
care for patients with malignant melanoma and with breast cancer but has yet to be
prospectively evaluated in patients with anal cancer.
Currently, the standard way to treat patients with anal cancer is to deliver a combination
of chemotherapy and radiation to the tumour at the anus together with 'preventative'
(prophylactic) radiotherapy to the lymph glands of the groin and pelvis. There is a growing
perception for the need to reduce the morbidity of radiotherapy i.e. current regimens
over-treat the patient and one approach is to reduce radiotherapy volume and/or dose where
there is an absence or very low risk of nodal metastases.
This feasibility study is a vital first step in informing the design of a larger study
examining the role of SLNB in clinical decision-making and outcomes for patients with anal
cancer. In this trial eligible patients will attend for lymphoscintigraphy, to locate the
lymph node, before sentinel lymph node removal by surgery. Detection rate of the sentinel
node(s) will be the key outcome for the study.
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Observational Model: Cohort, Time Perspective: Prospective
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