Carcinoma, Basal Cell Clinical Trial
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.
Verified date | October 2017 |
Source | Norwegian University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 277 |
Est. completion date | October 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Dept Dermatology, Haukeland University Hospital | Bergen | |
Norway | Central Hospital Førde | Førde | |
Norway | Hudlegekontoret Lillehammer AS | Lillehammer | |
Norway | Akerskus Dermatological Centre | Lørenskog | |
Norway | Dept Dermatology, Oslo University Hospital | Oslo | |
Norway | Dept Surgery, Oslo University Hospital | Oslo | |
Norway | Hudlegen på Holtet | Oslo | |
Norway | Dept Dermato-Venereology, Stavanger University Hospital | Stavanger | |
Norway | Department of Cancer Research and Molecular Medicine, NTNU | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | Akershus Dermatological Centre, Førde Central Hospital, Haukeland University Hospital, Helse Stavanger HF, Hudlegekontoret Lillehammer, Hudlegene på Holtet DA, Oslo University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | lesions response rate | Number of lesions in clinical complete response at follow-up | 3 years |
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