Metvix PDT Versus Cryotheraphy in Patients With Primary Superficial Basal Cell Carcinoma - Full Text View

Sponsored by:	PhotoCure
Information provided by:	PhotoCure
ClinicalTrials.gov Identifier:	NCT00469417

Purpose

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

MedlinePlus related topics: Cosmetics

Drug Information available for: Aminolevulinic acid Aminolevulinic acid hydrochloride Methyl aminolevulinate

U.S. FDA Resources

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

Further study details as provided by PhotoCure:

Primary Outcome Measures:

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 Outcome Measures:

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 ]

Enrollment:	120
Study Start Date:	October 1999
Study Completion Date:	May 2005

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A patient with superficial BCC lesion(s) suitable for entry was defined as a patient with:

histologically confirmed diagnosis of primary superficial BCC lesion(s)
BCC lesions suitable for cryotherapy
males or females above 18 years of age
written informed consent. In accordance with Amendment 2 (local amendment), only patients above 19 years of age were to be included in Austria.

Exclusion Criteria:

A patient or lesion fulfilling any of the following criteria was ineligible for inclusion:

prior treatment of the BCC lesion(s)
patients with more than 10 eligible BCC lesions
a superficial BCC lesion with the largest diameter exceeding 15 mm on face/scalp, larger than 20 mm on extremities and neck and larger than 30 mm on the trunk
a superficial BCC lesion with the largest diameter smaller than 6 mm
patient with porphyria
patient with Gorlin’s syndrome
pigmented superficial BCC lesion(s)
morpheaform lesion(s)
infiltrating lesion(s)
patients with a history of arsenic exposure
known allergy to Metvix®, a similar PDT compound or excipients of the cream
participation in other clinical studies either concurrently or within the last 30 days
pregnant or breast-feeding; all women of child-bearing potential had to document a negative pregnancy test and use the pill or intrauterine device during the treatments and for at least one month thereafter
conditions associated with a risk of poor protocol compliance.

In Amendment 1 the following exclusion criteria were added:

xeroderma pigmentosum lesion
concurrent use of immunosuppressive medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469417

Locations

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

Sponsors and Collaborators

PhotoCure

Investigators

Principal Investigator:

Nicole Basset-Séguin, Professor

Saint-Louis Hospital, Paris

More Information

Study ID Numbers:	PC T304/99
Study First Received:	May 3, 2007
Last Updated:	May 3, 2007
ClinicalTrials.gov Identifier:	NCT00469417
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

Keywords provided by PhotoCure:

Methyl aminolevulinate
Photodynamic therapy
Primary Superficial Basal Cell Carcinoma

Study placed in the following topic categories:

Methyl 5-aminolevulinate
Carcinoma, Basal Cell
Aminolevulinic Acid
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Photosensitizing Agents
Neoplasms
Neoplasms by Histologic Type
Radiation-Sensitizing Agents
Therapeutic Uses

Physiological Effects of Drugs
Neoplasms, Basal Cell
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009