Меню
Идёт набор NCT02702310

Low-Dose Total Skin Electron Therapy in Treating Patients With Refractory or Relapsed Stage IB-IIIA Mycosis Fungoides

— Наблюдательное Recurrent Mycosis Fungoides Refractory Mycosis Fungoides Stage I Mycosis Fungoides Stage II Mycosis Fungoides

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: Quality-of-Life Assessment, Objective Grading of Skin Findings.
Кому может быть актуально
Состояния в реестре: Recurrent Mycosis Fungoides, Refractory Mycosis Fungoides, Stage I Mycosis Fungoides, Stage II Mycosis Fungoides. 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
США
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

Prospective Observational Trial of Low-Dose Total Skin Electron Therapy in Mycosis Fungoides Using Rotisserie Technique

Обзор

This clinical trial studies low- dose total skin electron therapy in treating patients with stage IB-IIIA mycosis fungoides that has not responded to previous treatment (refractory) or has returned after a period of improvement (relapsed). Radiation therapy uses high energy electrons to kill tumor cells and shrink tumors. Rotisserie technique is a method in which the patient receives total skin electron therapy while standing on a rotating platform. Giving low dose total skin electron therapy using rotisserie technique may kill tumor cells, while having fewer side effects, and may allow therapy to be repeated in future if clinically indicated.

Подробное описание

PRIMARY OBJECTIVES:

I. To assess the skin-related quality of life using an established method (Skindex-29), with comparisons made between pre-treatment and each of follow-up post-treatment skin assessments.

II. To assess the durability of response using an established method (modified Severity-Weight Assessment \[mSWAT\] tool), with comparisons made between pre-treatment and each of follow-up post-treatment skin assessments.

III. To determine side effect profile for low dose total skin electron therapy (TSE) for mycosis fungoides administered via rotisserie technique.

OUTLINE:

The investigational portion of this research study involves collecting quality of life (QOL) questionnaire data and objective measurements of patients' skin responses, which are obtained by the radiation oncologist during the patient's standard of care radiation treatment planning. Patients will also undergo standard of care low-dose total skin electron therapy for under 1 hour daily on days 10-21.

After completion of study treatment, patients are followed up at 6 and 12 weeks, and then every 3 months thereafter.

Вмешательства

  • Другое Quality-of-Life Assessment
    At initial visit (day 1) - for determination of a baseline quality of life, patients will be given a self-reported questionnaire called the Skindex-29. Following standard of care radiation treatments, at weeks 6 \& 12, and every 3 months thereafter, patients will complete the Skindex-29 questionnaire.
  • Другое Objective Grading of Skin Findings
    At initial visit (day 1) , using mSWAT the radiation oncologist can follow the patient's treatment response by accurately grading the severity of the patient's skin findings. Following standard of care radiation treatments, at weeks 6 \& 12, and every 3 months thereafter, mSWAT will again be determined by physician. Follow-up visits will continue until patient has a change in disease.

Первичные конечные точки

  • Change in skin-related quality of life assessed by Skindex-29 [Срок оценки: Baseline to up to 3 years]
Вторичные конечные точки (2)
  • Change in the durability of response assessed by mSWAT tool [Срок оценки: Baseline to up to 3 years]
  • Incidence of side effects of low dose total skin electron therapy administered via rotisserie technique [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

  • Biopsy confirmed mycosis fungoides stage IB-IIIA
  • Skin manifestations of mycosis fungoides that are refractory to or have relapsed on at least one prior therapy, which may include topical steroids
  • Life expectancy > 6 months

Критерии исключения

  • Serious medical condition that would make treatment unsafe
  • Pregnant or lactating patient

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Vanderbilt-Ingram Cancer Center — Nashville

Публикации

  • Newman NB, Patel CG, Ding GX, Zic JA, Zwerner J, Osmundson EC, Kirschner AN. Prospective observational trial of low-dose skin electron beam therapy in mycosis fungoides using a rotational technique. J Am Acad Dermatol. 2021 Jul;85(1):121-127. doi: 10.1016/j.jaad.2020.12.023. Epub 2020 Dec 14. PMID 33333150

Идентификаторы

NCT: NCT02702310 · VICC RAD 1633 · NCI-2015-02293 · P30CA068485

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗