Treatment of Superficial Basal Cell Carcinoma by Topical Photodynamic Therapy With Fractionated 5-aminolevulinic Acid 20% Versus Two Stage Topical Photodynamic Therapy With Methylaminolevulinate
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 162
- Locations
- 3
- Primary Endpoint
- Treatment failure
Study Overview
Brief Summary
Skin cancer is the most common cancer in Caucasians, and a basal cell carcinoma (BCC) being the most common skin cancer with around 44,000 new tumours per year, and its incidence is still rising. In the past it has been a disease of the elderly patient but as a consequence of recreational sun exposure and tanning beds, more young patients develop a skin cancer as well. There are different subtypes of BCC and most subtypes are treated by surgical excision. Nowadays, non-invasive techniques as photodynamic therapy (PDT) are common practice to treat superficial BCC (sBCC). Because of these techniques treatment by surgical excision can be avoided with the possibility of complications and scar formation. Both 5-aminolevulino acid (5-ALA) and the more lipophilic methyl aminolevulinate (MAL) can be used as a precursor of the photosensitiser. These agents generate an excess of protoporphyrin IX in metabolic active cells, which are illuminated by a specific light source leading to release of reactive oxygen radicals in tissue. The result is apoptosis and necrosis of tumour cells. At the moment, two treatment protocols are used in the Netherlands: the fractionated 5-ALA 20% (Fagron) protocol according to de Haas and the MAL (Metvix, Galderma) protocol. Because MAL was first marketed and registered as a treatment option for premalignant and superficial malignancies most hospitals in the Netherlands use this topical agent. However, there is no evidence which of the 2 agents is more (cost-)effective and/ or preferred by patients.
Objective: to determine which treatment is the most effective treatment in terms of prevention of treatment failure, cost saving and patients preference when comparing fractionated 5-ALA 20% PDT versus MAL PDT in 2 treatment sessions.
Detailed Description
- Basal cell carcinoma throughout the world
Skin cancer is the most common form of cancer, with basal cell carcinoma (BCC) being the most common form of all skin cancers, and the incidence is still rising.1,2 Of all types of BCC, superficial basal cell carcinoma (sBCC), is the histopathologic subtype with the fastest growing incidence, especially on the trunk in younger patients.3-5 It is a common health problem and although there is no chance of metastasis it can lead to more aggressive forms of BCC with the ability to cause serious local destruction.
- Treatment options
The DBC (diagnose behandel combinatie) cost price, the amount received for diagnostic and treatment of one BCC, for surgical excision is partly free negotiable between each hospital and health insurances. Only the DBC cost price of patients whose health insurance has no contract with the hospital is public for everyone. This leads to around 18 million euro (based on a cost price of 400.00 euro for 44,000 new BCCs per year) that is yearly spent on the surgical treatment of BCC in the Netherlands and cost will only increase in future with the growing incidence.6 For most BCC subtypes the only effective treatment is surgery but for sBCC other non-invasive treatments like photodynamic therapy (PDT) are suitable. It is well accepted in today's dermatologic practice that surgical excision can be considered as over-treatment for sBCC.7-9 PDT is superior to surgical excision in primary sBCC of any size in low-risk sites.9 As a consequence unnecessary anaesthesia and incisions are avoided thereby preventing side-effects, such as scars, haematomas or functional disruption, and healthy tissue is preserved. MAL is a worldwide registered agent for the use of topical PDT in sBCC while 5-ALA is not registered in the European Union. In the Netherlands both fractionated 5-ALA 20% and MAL PDT in 2 sessions are used as treatment for sBCC. Although there are studies showing the effectiveness of both treatment regimens, the effectiveness, costs and patient preferences have never been studied in a prospective randomised trial.
- Developments in treatment: photodynamic therapy
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Minimal age of 18 years
- •Histological proven BCC
- •Primary BCC (no previous treatment)
- •Being able to understand instructions
Exclusion Criteria
- •Age under 18 years
- •No histological proven BCC
- •Recurrent BCC (previously treated)
- •Not able to understand instructions
- •Concomitant disease requiring systematic immunosuppressive treatment
- •Genetic skin cancer disorders
Arms & Interventions
Fractionated 5-ALA HCl 20% gel PDT
Twice on day 1
Intervention: Fractionated 5-aminolevulinic acid hydrochloride 20% gel PDT (Drug)
Methylaminolevulinate PDT in 2 sessions
On day 1 and 8
Intervention: Methylaminolevulinate PDT in 2 sessions (Drug)
Outcomes
Primary Outcomes
Treatment failure
Time Frame: 12 months posttreatment
Histological proven treatment failure one year after treatment of sBCC with fractionated 5-ALA 20% PDT versus MAL PDT in 2 sessions. If there is any clinical suspicion of residual tumour at control visits 3 and 12 months posttreatment, a 3 mm punch biopsy will be taken to confirm the diagnosis by histopathology.
Secondary Outcomes
- Health care costs(12 months posttreatment)
- Patient preferences(1 week posttreatment)