Clinical trial NCT01482104: New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC)
Official title: A Randomized Controlled Blinded Multi-centre Study of Photodynamic Therapy With Methyl-aminolevulinate Comparing a Simplified Regime With the Approved Regime in Patients With Clinical Low-risk Superficial and Nodular Basal Cell Carcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Neoplasms
Carcinoma, Basal Cell
Keywords: Photochemotherapy
methyl 5-aminolevulinate
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Akershus Dermatological Centre
name: Helse Stavanger HF
name: Oslo University Hospital
name: Førde Central Hospital
name: Haukeland University Hospital
name: Hudlegekontoret Lillehammer
name: Hudlegene på Holtet DA
First posted: 2011-11-30
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Basal cell carcinoma (BCC) is the most common malignant skin lesion in white adults. It is a slow-growing tumour which despite low metastatic potential may cause significant local tissue destruction and patient morbidity. Methyl aminolevulinate cream plus photodynamic therapy (MAL-PDT) for BCC is currently approved for a procedure using 2 treatment sessions 1 week apart. This procedure is considered quite time- and resource-consuming. Introducing a single treatment session, with a new PDT session for treatment failures after 3 months, might represent an attractive simplification.

This randomised controlled single-blinded multi-centre study primarily aims to compare BCC lesion response rate of two treatment schedules: (a) 1 single treatment of Metvix-PDT with re-treatment of non-complete responders by 3 months, and (b) the usual schedule of 2 standard Metvix(R) PDT treatments 1 week apart.

Secondary objectives are to investigate the treatment response in relation to clinical and histological tumour characteristics such as tumour thickness, subtype and immunohistochemical markers.


Eligibility criteria: Inclusion Criteria:

* male/female above 18 years of age
* written informed consent
* 1 or more primary histologically verified BCC, clinically assessed as of either superficial of nodular type

Exclusion Criteria:

* pregnancy
* breastfeeding
* Gorlin's syndrome
* porphyria
* xeroderma pigmentosum
* history of arsenic exposure
* known allergy to MAL
* concomitant treatment with immunosuppressive medication
* physical or mental conditions that most likely will prevent patients attending follow-up sessions

Primary outcomes:
measure: lesions response rate
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Dept Dermatology, Haukeland University Hospital
city: Førde
country: Norway
facility: Central Hospital Førde
city: Lillehammer
country: Norway
facility: Hudlegekontoret Lillehammer AS
city: Lørenskog
country: Norway
facility: Akerskus Dermatological Centre
city: Oslo
country: Norway
facility: Dept Dermatology, Oslo University Hospital
city: Oslo
country: Norway
facility: Dept Surgery, Oslo University Hospital
city: Oslo
country: Norway
facility: Hudlegen på Holtet
city: Stavanger
country: Norway
facility: Dept Dermato-Venereology, Stavanger University Hospital
city: Trondheim
country: Norway
facility: Department of Cancer Research and Molecular Medicine, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Magne Børset, PhD prof
role: STUDY_DIRECTOR
References: