Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 5FU-Calcipotriol, 5-FU 50 MG/ML Topical Cream.
- Who it may be relevant to
- Registry conditions: Actinic Keratoses. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis: a Multicentre Randomized Controlled Clinical Trial
Overview
5-Fluorouracil (5FU) is proven to be the most effective therapy in field directed treatment for AK, with Jansen et al. reporting a 1-year probability of treatment success of 74.7%. However, treatment with 5FU is associated with side effects, like erythema, itching, a burning sensation and crusting, and a burdensome dosing regimen of twice daily application for four weeks. This long treatment duration in combination with side-effects and overall lifestyle adjustments during treatment can be the reason for poor adherence and premature termination, and it can also lead to future refusal of 5FU therapy. Therefore, room for improvement lies in increasing the tolerability, in terms of side effects or treatment duration, while maintaining the efficacy of 5FU in the treatment of AK. Addition therapy, which can shorten the duration of treatment, might be the key to success. Calcipotriol (CAL) enhances thymic stromal lymphopoietin (TSLP), an epithelium-derived cytokine, which promotes antitumor immunity. Therefore, it is known to have a synergistic effect when combined with 5FU in the treatment of AK. This suggests that short-term treatment with 5FU-CAL is effective and provides the opportunity to shorten duration of treatment, thereby improving tolerability of treatment and full adherence to the treatment regimen. However, no study compared 5FU-CAL combination therapy with standard 5FU treatment for a duration of 28 days. This study aims to evaluate whether a short course of combination therapy with 5FU-CAL is non-inferior to a full course of 5FU monotherapy with respect to the 1-year probability of treatment success.
Interventions
- Drug 5FU-Calcipotriol
topical 5FU-CAL, twice daily, during 4 or 6 consecutive days, depending on the treatment location - Drug 5-FU 50 MG/ML Topical Cream
topical 5FU, twice daily, 7 days a week, during 4 weeks
Primary outcome measures
- Treatment success at 12 months post-treatment [Time frame: 12 months after finishing treatment]
Secondary outcome measures (6)
- AK clearance rate [Time frame: 3 and 12 months after finishing treatment]
- Recurrence rate [Time frame: 3 and 12 months after finishing treatment]
- Adverse effects [Time frame: During treatment and 3 months post-treatment]
- Treatment compliance [Time frame: During treatment]
- Patient satisfaction [Time frame: 3 and 12 months post-treatment]
- Quality of life before, during and after treatment [Time frame: Baseline, 1 week after finishing treatment and 3 and 12 months post-treatment]
Eligibility criteria
Inclusion criteria
- Adults above 18 years of age
- Clinical and dermoscopical diagnosis of AK by a dermatologist, in one or more area(s):
- Face, ears, (balding) scalp
- Neck/Shawl area, including the sun-exposed chest area
- Upper extremities
- Number of AK lesions ≥4 in a continuous treatment area of up to 100 cm2
- AK Olsen grade I-III
Exclusion criteria
- Previous field treatment for AK within 2cm of the treatment area, within 3 months
- (non) melanoma skin cancer in treatment area
- Mucosal lesions
- Genetic skin cancer disorder
- Women who are pregnant or breastfeeding
- Women of childbearing potential, who are not willing to use effective contraceptive measures
- Previous allergy or intolerance to either 5FU or calcipotriol
- Patients with known contra-indications for calcipotriol use: previous diagnosis of hyper-calcemia, disturbed calcium metabolism, severe kidney or liver dysfunction
- Concurrent use of oral capecitabine or any other topical or systemic chemopreventive agent for any indication
- Concurrent use of other topical treatments registered as treatment for AK
- Limited understanding of the Dutch language and not being able to give informed consent (incapacitated patients)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Netherlands · 4 centers
- Zuyderland Medical Center — Heerlen
- Maastricht University Medical Center — Maastricht
- VieCuri Medical Center — Venlo
- Catharina Hospital Eindhoven — Eindhoven
Identifiers
NCT: NCT06499415 · 2024-511409-42-00