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Идёт набор NCT07443475

Electrochemotherapy for Recurrent Vulvar Cancer

Фаза II С лечением Vulvar Cancer Recurrent Vulvar Cancer

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: Electrochemotherapy (ECT).
Кому может быть актуально
Состояния в реестре: Vulvar Cancer, Recurrent Vulvar Cancer. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Словения
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Use of Electrochemotherapy in Women With Vulvar Cancer

Обзор

This phase I/II interventional study evaluates the effectiveness and safety of electrochemotherapy (ECT) as neoadjuvant treatment for local recurrence of vulvar cancer. Electrochemotherapy combines intravenous administration of bleomycin with delivery of electric pulses to the tumor area, increasing drug uptake into cancer cells. The main goal is to assess tumor response and reduce the need for mutilating surgical procedures, thereby improving quality of life in women with recurrent vulvar cancer. Participants will be followed prospectively and treatment outcomes will be evaluated using RECIST criteria and adverse events using CTCAE v5.0.

Подробное описание

This is a prospective phase I/II institutional interventional clinical study conducted at the Institute of Oncology Ljubljana. The study investigates electrochemotherapy (ECT) as neoadjuvant treatment for women with local recurrence of vulvar cancer. ECT is performed according to ESOPE standard operating procedures, using systemic administration of bleomycin followed by delivery of electric pulses to the tumor and surrounding safety margin. Tumor response will be assessed clinically according to RECIST criteria, and adverse events will be recorded according to CTCAE version 5.0. Quality of life will be evaluated using EQ-5D questionnaire, pain VAS diary, and patient willingness to undergo ECT again. The ECT-treated group will be compared with a matched control group of patients previously treated surgically for recurrent vulvar cancer at the same institution. The planned study duration is 5 years (September 2021-August 2026), with planned enrollment of 20 patients aged 18 years or older.

Вмешательства

  • Процедура Electrochemotherapy (ECT)
    Electrochemotherapy consists of intravenous bleomycin administration followed by delivery of electric pulses to the tumor area using appropriate electrodes, in accordance with ESOPE standard operating procedures. Electric pulses increase cell membrane permeability and enhance bleomycin uptake in tumor tissue.

Первичные конечные точки

  • Objective Tumor Response Rate (RECIST) [Срок оценки: Up to 30 days after electrochemotherapy]
Вторичные конечные точки (4)
  • Incidence of Adverse Events (CTCAE v5.0) [Срок оценки: From treatment until 30 days after electrochemotherapy]
  • Quality of Life (EQ-5D Questionnaire) [Срок оценки: Baseline and during follow-up visits up to 5 years]
  • Pain Intensity (VAS Diary) [Срок оценки: From treatment through follow-up visits up to 30 days]
  • Length of Hospital Stay [Срок оценки: During hospital stay]

Критерии участия

Критерии включения

  • Local recurrence of vulvar cancer
  • Age ≥ 18 years
  • Expected life expectancy > 3 months
  • Karnofsky performance status ≥ 70 or WHO performance status ≤ 2
  • At least 2 weeks since last treatment
  • Ability to understand the procedure and possible adverse effects
  • Ability to provide written informed consent
  • Patient discussed at multidisciplinary tumor board before enrollment
  • Fit for anesthesia

Критерии исключения

  • Life-threatening infection and/or severe cardiac, hepatic, or other systemic disease
  • Significantly reduced lung function requiring DLCO testing (patients with abnormal DLCO are excluded)
  • Age < 18 years
  • Major coagulation disorders not responding to standard therapy
  • Prior cumulative bleomycin dose ≥ 400 mg/m²
  • Chronic renal impairment (creatinine > 150 µmol/L)
  • Epilepsy
  • Pregnancy
  • Inability to understand the study or refusal to participate

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Словения · 1 центр
  • Institute of Oncology Ljubljana — Ljubljana

Идентификаторы

NCT: NCT07443475 · OI-EKT-VULVA-2021 · ERID-KSOPR-0026/2023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗