The aim of the present study is to study Metvix® photodynamic therapy (MAL-PDT) of superficial basal cell carcinoma (sBCC) using two light fractions with one or two hours interval: comparison of illumination at 3 (20 J/cm2) and 4 hours (55 J/cm2)…
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary efficacy end point includes the individual sBCC lesion total clearance
rate at 3 months.
Secondary outcome
Secundary endpoints include:
- Reduction in treated lesion size from day 1 at 3 months and 12 months in
each group
- Relapse rate at 12 months of lesions in complete response in each group
- Mean VAS score after each MAL-PDT fractionated treatment in each group
- Incidence and severity of adverse event throughout the study
Background summary
Basal cell carcinoma (BCC) is the most common forms of all cancers. The
incidence is still rising with 6 to 10 percent each year. The incidence of BCC
is even rising in young adults, particularly among women. Besides the problem
of more patients with BCC, the number of new tumours per patient is also
rising. This growing health and economic problem asks for adequate and
effective treatment options to become available.
For the superficial BCC subtype, surgery and methyl aminolevulinate
photodynamic treatment (Metvix® or MAL-PDT) are the best documented and
evidence based therapies. Surgical procedures are highly effective but are
painful and cause scarring. MAL-PDT however is non-invasive and has good
cosmetic results.
MAL-PDT is a 2-step procedure. In the first step, Metvix® (methyl
aminolevulinate, MAL) is administered to the patient as a cream and it is
allowed to be taken up in the skin. In the second step the tumour is exposed
to red light. Illumination takes place 3 hours after the MAL cream was first
applied. Although this treatment protocol is highly effective, the double
procedure with the one week interval is not that practical for patients and
costly for the health system.
Aim of this study is to assess whether MAL-PDT is also effective when given as
a fractioned treatment on one day. Effectiveness of such a fractioned treatment
had already been proven for aminolevulinic acid-PDT (ALA-PDT). Up till now,
there are no clinical studies of fractionated MAL-PDT in sBCC. Given the
benefits for patients and lower costs for the health system, it is important to
evaluate this fractioned treatment.
Study objective
The aim of the present study is to study Metvix® photodynamic therapy (MAL-PDT)
of superficial basal cell carcinoma (sBCC) using two light fractions with one
or two hours interval: comparison of illumination at 3 (20 J/cm2) and 4 hours
(55 J/cm2) with illumination at 3 (20 J/cm2) and 5 hours (55 J/cm2) after
application of MAL. The total light dose is 75 J/cm2, according to the standard
protocol for MAL-PDT in sBCC (2 sessions 37J/cm² one week apart with 630 nm
lamp). Furthermore, this study aims to analyze the sampling error within punch
biopsies, diagnosed as sBCC using the current examination method, using a more
extensive examination process.
Study design
A multi-centre, prospective, randomized, investigator blind, investigator
initiated post marketing pilot study.
Study duration: 2 years
Setting: Radboud University Nijmegen Medical Centre, Maxima Medical Centre in
Eindhoven
Intervention
In the present study two different illuminations schemes will be compared:
- MAL-PDT using two light fractions with one hour interval: illumination at 3
(20 J/cm2) and 4 hours (55 J/cm2) after application of MAL (red light, Aktilite
128).
- MAL-PDT using two light fractions with two hours interval: illumination 3 (20
J/cm2) and 5 hours (55 J/cm2) after application of MAL (red light, Aktilite
128).
Study burden and risks
We don*t expect extra risks, as there were none in patients treated with
fractionated ALA-PDT. There are no extra procedures except for a more detailed
documentation of the lesions and VAS for pain, at the start and during the
follow up. This will take an extra 5 minutes at each visit.
Rene Descartesdreef 1
Nijmegen 6525 GL
NL
Rene Descartesdreef 1
Nijmegen 6525 GL
NL
Listed location countries
Age
Inclusion criteria
- Age 18 years or above;- Male and female;- Primary sBCC with size between 1-2 cm;- Willingly to sign a written informed consent
Exclusion criteria
- Known allergy to MAL or related compounds, or excipients of the cream ;- Participation in other clinical studies in the last 30 days;- Other treatments for skin cancer in the area to be treated in the last 12 weeks;- Likelihood of noncompliance ;- Chronic immunosuppression;- Pregnant or breast-feeding
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-004173-12-NL |
| CCMO | NL41859.091.12 |