Carcinoma, Basal Cell Clinical Trial
Official title:
A Randomized Controlled Blinded Multi-centre Study of Photodynamic Therapy With Methyl-aminolevulinate Comparing a Simplified Regime With the Approved Regime in Patients With Clinical Low-risk Superficial and Nodular Basal Cell Carcinoma.
Basal cell carcinoma (BCC) is the most common malignant skin lesion in white adults. It is a
slow-growing tumour which despite low metastatic potential may cause significant local tissue
destruction and patient morbidity. Methyl aminolevulinate cream plus photodynamic therapy
(MAL-PDT) for BCC is currently approved for a procedure using 2 treatment sessions 1 week
apart. This procedure is considered quite time- and resource-consuming. Introducing a single
treatment session, with a new PDT session for treatment failures after 3 months, might
represent an attractive simplification.
This randomised controlled single-blinded multi-centre study primarily aims to compare BCC
lesion response rate of two treatment schedules: (a) 1 single treatment of Metvix-PDT with
re-treatment of non-complete responders by 3 months, and (b) the usual schedule of 2 standard
Metvix(R) PDT treatments 1 week apart.
Secondary objectives are to investigate the treatment response in relation to clinical and
histological tumour characteristics such as tumour thickness, subtype and immunohistochemical
markers.
n/a
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