To prospectively study if patients carrying clinically relevant DPYD variants (DPYD*2A, c.2846A>T, c.1236G>A/HapB3, c.1679T>G) are more at risk for developing moderate/severe vesicles or bullae with 5-FU cream.
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Health condition
Actinic keratosis, morbus Bowen or superficial basal cell carcinoma
Research involving
Sponsors and support
Intervention
- Other intervention
Outcome measures
Primary outcome
Appearing of moderate or severe vesicles or bullae in patients treated with 5-FU cream
Secondary outcome
- Pharmacokinetics of 5-FU cream. - Appearing of erythema, swelling, erosion, crusting, scaling, itching, diarrhea and/or fatigue. - Severity of pain and burning sensation. - Time to onset of severe 5-FU cream related toxicities; appearing of vesicles/bullae, erythema, swelling, erosion, crusting, scaling, itching, diarrhea and/or fatigue. - Tumour response at 3 months.
Background summary
Rationale: Recently it was shown that DPYD genotype-based dose reductions improved patient safety of fluoropyrimidine treatment. A limitation of previous research is that the additional value of DPYD genotype-based dosing is based on therapy with 5-fluoropyrimidine (5-FU; intravenous) and capecitabine (oral), while there is a third application of 5-FU; topical 5-FU (Efudix 5% cream). Objective: To study if patients who carry clinically relevant DPYD variants (DPYD*2A, c.2846A>T, c.1236G>A/HapB3, c.1679T>G) are at a higher risk for developing severe 5-FU cream-related toxicity. Study design: Prospective, observational clinical trial. Of patients receiving 5-FU cream, one blood sample will be withdrawn before or during therapy for DPYD genotyping. On five time points (1, 2 and 3 weeks after start therapy, with stop therapy and 3 months after start) adverse events will be evaluated using visual inspection of the treated area and patients will be asked to complete diaries to obtain information about adverse events. Study population: Adult patients planned to receive 5-FU cream are asked to participate in the study. Main study parameters/endpoints: Severe toxicity in patients treated with 5-FU cream. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk of blood withdrawals is negligible.
Study objective
To prospectively study if patients carrying clinically relevant DPYD variants (DPYD*2A, c.2846A>T, c.1236G>A/HapB3, c.1679T>G) are more at risk for developing moderate/severe vesicles or bullae with 5-FU cream.
Study design
First patient inclusion planned in November 2019.
Intervention
-
Niels Heersche
Dr. Molewaterplein 40
3015 GD
Rotterdam
The Netherlands
010-7040799
n.heersche@erasmsumc.nl
Niels Heersche
Dr. Molewaterplein 40
3015 GD
Rotterdam
The Netherlands
010-7040799
n.heersche@erasmsumc.nl
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age ≥ 18 years - Able to understand the written information and able to give informed consent - Planned treatment with topical 5-FU cream (Efudix) for any indication - Possibility to take photos of the treatment area at the designated times and send them digitally
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study: - Prior treatment with fluoropyrimidines - Known allergy to (components of) 5-FU cream - Pregnancy, breast-feeding, active child wish - Concomitant use of systemic retinoids - Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient’s safety in the opinion of the treating physician
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8075 |
| CCMO | NL70969.078.19 |
| OMON | NL-OMON54797 |