Metvix PDT Versus Cryotherapy in Patients With Primary Superficial Basal Cell Carcinoma
|First Submitted Date ICMJE||May 3, 2007|
|First Posted Date ICMJE||May 4, 2007|
|Last Update Posted Date||September 3, 2010|
|Start Date ICMJE||October 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00469417 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||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 ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Metvix PDT Versus Cryotherapy in Patients With Primary Superficial Basal Cell Carcinoma|
|Official Title ICMJE||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 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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Superficial Basal Cell Carcinoma|
|Intervention ICMJE||Procedure: Cryotherapy or Photodynamic therapy with methyl aminolevulinate cream|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||May 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
A patient with superficial BCC lesion(s) suitable for entry was defined as a patient with:
A patient or lesion fulfilling any of the following criteria was ineligible for inclusion:
In Amendment 1 the following exclusion criteria were added:
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Austria, Belgium, Finland, France, Italy, Sweden, United Kingdom|
|Removed Location Countries|
|NCT Number ICMJE||NCT00469417|
|Other Study ID Numbers ICMJE||PC T304/99|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Galderma|
|Collaborators ICMJE||Not Provided|
|Verification Date||September 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP