A Multicenter, Phase III, Randomised Study of Photodynamic Therapy With Metvix Cream 160 mg/g in Comparison With Cryotherapy in Patients With Primary Superficial Basal Cell Carcinoma
BCC is a highly frequent skin malignancy, and accounts for approximately 75% of all
non-melanoma skin cancers. It is the most common malignant tumour of any organ, mostly
affecting head and neck (84%) in fair-skinned people. Several non-pharmacological treatment
modalities are used for BCC, including excision surgery, Moh's surgery, radiation,
curettage/electrodesiccation and cryotherapy. The treatment used depends on the type, size,
depth and localisation of the BCC lesion.
The use of PDT is attractive for the treatment of BCCs because of its efficiency, mild and
local side effects and excellent cosmetic outcome. Previous clinical experience is promising
and patients with primary BCCs will be included in this prospective, randomised,
comparative, multicenter study to show that Metvix is non-inferior to alternative treatment
with better cosmetic outcome.
The primary end-point will be the number of patients in whom 75% or more of the BCC lesions
have responded completely at 3 months after PDT with Metvix or 3 months after cryotherapy.
Both on-site and independent, blinded response assessments will be analysed. The analysis
based on the results of the independent review board constitutes the primary analysis.
The secondary end-points will be the proportion of patients in whom less than 75% of the BCC
lesions respond completely, number of lesions across patients that show complete response,
evaluation of cosmetic outcome and adverse events 3 months after Metvix PDT or 3 months
after cryotherapy. In addition 12, 24, 36, 48 and 60 months recurrence rates will be
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary end-point will be the number of patients in whom 75% or more of the BCC lesions have responded completely at 3 months after PDT with Metvix or 3 months after cryotherapy
3 months after treatment
Nicole Basset-Séguin, Professor
Saint-Louis Hospital, Paris
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)