Surgical Excision Versus Photodynamic Therapy and Topical 5-fluorouracil in Treatment of Bowen's Disease
Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
There is limited quality research on the effectiveness of treatments in Bowen's disease (BD).
Patient and lesion characteristics, patient preferences and costs should be considered when
choosing therapy. Surgical excision (SE), photodynamic therapy (PDT) and 5-fluorouracil (5FU)
are mentioned as treatment options in guidelines. However no clear and evidence based
recommendations are made in terms of effectiveness.
Objective: The aim of this study is 1) to evaluate the (cost)effectiveness of 5FU and PDT
compared to SE in BD and 2) to compare the effectiveness of 5FU with that of PDT. With a
better understanding of the (cost)effectiveness of alternative treatment options, the
investigators will supply the necessary evidence for national and international guidelines,
to achieve more uniformity in treatment of BD.
Study design: Randomized controlled non-inferiority multicenter trial. Study population:
Patients ≥18 years, with a histological proven primary lesion of Bowen's disease, visiting
Maastricht University Medical Centre, Catharina hospital Eindhoven, VieCuri MC Venlo or
Zuyderland Medical Centre Heerlen.
Intervention: One group undergoes SE with a 5mm safety margin followed by routine
histological examination. The other group receives PDT with application of methyl
aminolevulinate (MAL) cream followed by two illuminations with a one-week interval. The third
group receives 5FU cream, which has to be applied by the patient twice daily for 4 weeks.
Main study parameters/endpoints: The primary outcome is the proportion of patients with
sustained clearance at 12 months post-treatment. Secondary outcomes are proportion of
patients with clearance at 3 months, 3-year and 5-year probability of sustained clearance,
cost-effectiveness, patient satisfaction, patient preferences, compliance, side effects and
cosmetic outcome. Post-treatment, patients will be asked to answer a short questionnaire
regarding side effects, experience with the treatment and satisfaction.