Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
PhotoCure |
---|---|
Information provided by: | PhotoCure |
ClinicalTrials.gov Identifier: | NCT00469417 |
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.
Condition | Intervention | Phase |
---|---|---|
Superficial Basal Cell Carcinoma |
Procedure: Cryotherapy or Photodynamic therapy with methyl aminolevulinate cream |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 120 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A patient with superficial BCC lesion(s) suitable for entry was defined as a patient with:
Exclusion Criteria:
A patient or lesion fulfilling any of the following criteria was ineligible for inclusion:
In Amendment 1 the following exclusion criteria were added:
Austria | |
University of Graz | |
Graz, Austria, 8036 | |
Belgium | |
Universitaire Ziekenhuizen Leuven | |
Leuven, Belgium, B3000 | |
Finland | |
Helsinki University Central Hospital | |
Helsinki, Finland, 00029 | |
France | |
Service de Dermatologie, C.H.U Saint Louis | |
Paris, France, 754747 | |
Hôpital Sainte-Marguerite | |
Marseille, France, 13277 | |
Italy | |
Spedali di Brescia | |
Brescia, Italy, 25125 | |
Sweden | |
Huddinge Sjukhus | |
Stockholm, Sweden, 14186 | |
Regionsjukhuset i Örebro | |
Örebro, Sweden, 70185 | |
Länsjukhuset Ryhov | |
Jönköping, Sweden, 55185 | |
Universitetssjukhuset | |
Linköping, Sweden, 58185 | |
United Kingdom | |
Ninewells Hospital | |
Dundee, United Kingdom, DDI 954 | |
University of Wales | |
Cardiff, United Kingdom, CF4 4XN | |
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 |
Study ID Numbers: | PC T304/99 |
Study First Received: | May 3, 2007 |
Last Updated: | May 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00469417 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Sweden: Medical Products Agency; Austria: Agency for Health and Food Safety; Finland: National Agency for Medicines |
Methyl aminolevulinate Photodynamic therapy Primary Superficial Basal Cell Carcinoma |
Photosensitizing Agents Radiation-Sensitizing Agents Methyl 5-aminolevulinate Neoplasms, Basal Cell |
Carcinoma, Basal Cell Aminolevulinic Acid Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms by Histologic Type Physiological Effects of Drugs Methyl 5-aminolevulinate Carcinoma, Basal Cell Pharmacologic Actions Carcinoma Aminolevulinic Acid |
Neoplasms Photosensitizing Agents Radiation-Sensitizing Agents Therapeutic Uses Neoplasms, Basal Cell Dermatologic Agents Neoplasms, Glandular and Epithelial |