Metvix PDT Versus Cryotherapy in Patients With Primary Superficial Basal Cell Carcinoma
The purpose of this study is to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to cryotherapy, in treatment of patients with primary superficial basal cell carcinoma.
Secondary objectives are to compare cosmetic outcome and tolerability (adverse events) in these patients, 3 months after treatment. In addition the recurrence rates in the two treatment groups will be compared up to five years after treatment.
Superficial Basal Cell Carcinoma
Procedure: Cryotherapy or Photodynamic therapy with methyl aminolevulinate cream
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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 [ Time Frame: 3 months after treatment ]
- Secondary end-points: proportion of patients with less than 75% lesion complete response, number of lesions that show complete response, cosmetic outcome and adverse events. In addition 12, 24, 36, 48 and 60 months recurrence rates will be assessed. [ Time Frame: Up to 60 months after treatment ]
|Study Start Date:||October 1999|
|Study Completion Date:||May 2005|
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 assessed.
|University of Graz|
|Graz, Austria, 8036|
|Universitaire Ziekenhuizen Leuven|
|Leuven, Belgium, B3000|
|Helsinki University Central Hospital|
|Helsinki, Finland, 00029|
|Marseille, France, 13277|
|Service de Dermatologie, C.H.U Saint Louis|
|Paris, France, 754747|
|Spedali di Brescia|
|Brescia, Italy, 25125|
|Jönköping, Sweden, 55185|
|Linköping, Sweden, 58185|
|Stockholm, Sweden, 14186|
|Regionsjukhuset i Örebro|
|Örebro, Sweden, 70185|
|University of Wales|
|Cardiff, United Kingdom, CF4 4XN|
|Dundee, United Kingdom, DDI 954|
|Falkirk and District Royal Infirmary|
|Falkirk, United Kingdom, F1 5QE|
|Glasgow University Hospital|
|Glasgow, United Kingdom, GI2 8QQ|
|Principal Investigator:||Nicole Basset-Séguin, Professor||Saint-Louis Hospital, Paris|