E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bowens's disease |
Morbus Bowen |
|
E.1.1.1 | Medical condition in easily understood language |
Bowen's disease is a superficial form of skincancer. |
De ziekte van Bowen is een oppervlakkige vorm van huidkanker. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the (cost)effectiveness of 5-fluorouracil cream (5FU) and photodynamic therapy (PDT), compared to surgical excision (SE) in Bowen’s Disease (BD). |
Het doel is om de (kosten)effectiviteit van 5-fluorouracil cream (5FU) en photodynamische therapie (PDT), te vergelijken met chirurgische excisie in morbus Bowen. |
|
E.2.2 | Secondary objectives of the trial |
To compare the effectiveness of 5-fluorouracil cream (5FU) with that of photodynamic therapy (PDT) in Bowen’s Disease (BD).
To examine if 5-fluorouracil cream (5FU) and photodynamic therapy (PDT) result in greater patient satisfaction and/or cosmetic result compared to surgical excision (SE) in Bowen’s Disease (BD). |
Om de (kosten)effectiviteit van 5-fluorouracil cream (5FU) te vergelijken met photodynamische therapie (PDT)in morbus Bowen.
Onderzoeken of 5-fluorouracil (5FU) en photodynamische therapie (PDT) resulteert in meer patient tevredenheid en/of cosmetiek in vergelijking tot chirurgische excisie in morbus Bowen. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Adults ≥ 18 years
-Histologically proven primary Bowen’s disease
-Lesions ≥ 4mm and ≤ 40mm in diameter
-Fitzpatrick skin type I-IV
-Female in child bearing potential should be using contraceptive measures, during and till 3 months post-treatment
|
-Volwassenen≥ 18 jaar
-Histologisch bewezen primaire morbus Bowen
Lesies ≥ 4mm en ≤ 40mm in diameter
-Fitzpatrick huid type I-IV
-Vrouwen die zwanger kunnen worden moeten anticonceptie maatregelen nemen, tijdens en 3 maanden na behandeling |
|
E.4 | Principal exclusion criteria |
-Bowen's Disease located at ears, periocular, nail , nail unit or periungual tissue, nose (limited light exposure for PDT) and mucous membranes (different entities)
-High clinical suspicion of invasive SCC
-(N)MSC in target area
-Breastfeeding
-Pregnancy
-Allergy to study drugs
-Not able to self-apply cream on lesions located on the back or other difficult to reach locations
-Genetic skin cancer disorders
-Not understanding Dutch language
-Porphyria
-Not able to give informed consent
-Immuno-compromised status
-Use of systemic retinoid in the past 3 months
-Use of immunosuppressant drugs in the past 3 months and / or at time of treatment (such as oral glucocorticoids, cytostatic, antibodies, drug acting on immunophilins, in-terferon, opioids, TNF binding proteins, MMF, biologic agents). inhalation corticoster-oids / nasal corticosteroids are permitted.
|
-Locatie van M. Bowen op oren, perioculair, nagel/nagelbed, neus en slijmvliezen
-Hoge klinische verdenking plaveiselcelcarcinoom
-(N)MSC in gebied van behandeling
-Borstvoeding
-Zwangerschap
-Allergie voor medicatie in de studie
- Niet in staat om zelf crème aan te brengen op laesies op de rug of andere moeilijk te bereiken locaties
-Genetische huidkanker syndroom
-Geen begrip van Nederlandse taal
-Porfyrie
-Niet in staat om informed consent te geven
-Immuun gecompromiteerde status
-Gebruik van systemische retinoid in de afgelopen 3 maanden
-Gebruik van immuunsuppresieve medicatie in 3 maanden voor de studie of tijdens studie
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients with sustained clearance. |
Proportie van patienten met complete respons. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At 3 and 12 months and 2-years and 5-years post treatment. |
3 en 12 maanden en 2 jaar en 5 jaar na behandeling. |
|
E.5.2 | Secondary end point(s) |
Cost-effectiveness, side effects, cosmetic outcome, patient satisfaction, patient preference and compliance. |
Kosten-effectiviteit, bijwerkingen, cosmetiek, patient tevredenheid, patient voorkeur en therapietrouw. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At 3 and 12 months |
3 en 12 maanden |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
chirurgische excisie |
Surgical excision |
|
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |