This research has the goal to determine which treatment is the most effective treatment in terms of prevention of treatment failure, in costs and has the patients preference when comparing PDT, Imiquimod and 5FU.
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome measures: The primary outcome measure is treatment failure within 12
months after treatment.
Secondary outcome
Secondary outcome measures are degree of pain experienced during treatment,
compliance with treatment, side effects of treatment, patient preferences and
health care costs.
Background summary
Skin cancer is the most common cancer in Caucasians, and a basal cell carcinoma
(BCC) being the most common skin cancer with 36.000 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 (Photodynamic therapy (PDT), imiquimod and
5-fluorouracil (5FU)) are common practice to treat superficial BCC (sBCC).
Because of these techniques treatment by an excision can be avoided with the
possibility of complications and scar formation. Which treatment the patient
will receive, does not rely on evidence based medicine but on the preference of
the physician; there are no data regarding cost-effectiveness or patients
preference.
Study objective
This research has the goal to determine which treatment is the most effective
treatment in terms of prevention of treatment failure, in costs and has the
patients preference when comparing PDT, Imiquimod and 5FU.
Study design
Study design: a randomized controlled multi-centre study
-
Intervention
Intervention: PDT versus imiquimod versus 5-fluorouracil
-
Study burden and risks
not applicable
P. Debyelaan 25
6202 AZ Maastricht
NL
P. Debyelaan 25
6202 AZ Maastricht
NL
Listed location countries
Age
Inclusion criteria
All patients with a primary (no previous treatment) histopathologically confirmed diagnosis of one or more sBCCs aged between 18 and 80 years old.
Exclusion criteria
Patients using immunosuppressive drugs, patients with genetic skin cancer disorders, location in the H-zone or the hairy head, earlier treatments at the same site and pregnancy.
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 | EUCTR2007-002776-33-NL |
| CCMO | NL17969.068.07 |