Меню
Идёт набор NCT06499415

Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis

Фаза IV С лечением Actinic Keratoses

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 5FU-Calcipotriol, 5-FU 50 MG/ML Topical Cream.
Кому может быть актуально
Состояния в реестре: Actinic Keratoses. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis: a Multicentre Randomized Controlled Clinical Trial

Обзор

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.

Вмешательства

  • Препарат 5FU-Calcipotriol
    topical 5FU-CAL, twice daily, during 4 or 6 consecutive days, depending on the treatment location
  • Препарат 5-FU 50 MG/ML Topical Cream
    topical 5FU, twice daily, 7 days a week, during 4 weeks

Первичные конечные точки

  • Treatment success at 12 months post-treatment [Срок оценки: 12 months after finishing treatment]
Вторичные конечные точки (6)
  • AK clearance rate [Срок оценки: 3 and 12 months after finishing treatment]
  • Recurrence rate [Срок оценки: 3 and 12 months after finishing treatment]
  • Adverse effects [Срок оценки: During treatment and 3 months post-treatment]
  • Treatment compliance [Срок оценки: During treatment]
  • Patient satisfaction [Срок оценки: 3 and 12 months post-treatment]
  • Quality of life before, during and after treatment [Срок оценки: Baseline, 1 week after finishing treatment and 3 and 12 months post-treatment]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Нидерланды · 4 центра
  • Zuyderland Medical Center — Heerlen
  • Maastricht University Medical Center — Maastricht
  • VieCuri Medical Center — Venlo
  • Catharina Hospital Eindhoven — Eindhoven

Идентификаторы

NCT: NCT06499415 · 2024-511409-42-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗