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Идёт набор NCT03785288

Vaginal Cuff Brachytherapy Fractionation Study

Фаза III С лечением Endometrial 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: HDR vaginal brachytherapy.
Кому может быть актуально
Состояния в реестре: Endometrial 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
США
Следующий шаг
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Официальное название

A Randomized Phase III Trial of Two Standard Dose Fractionation Regimes for Adjuvant Vaginal Brachytherapy in Early Stage Endometrial Cancer

Обзор

The purpose of this study is to see the effects of two different standard of care treatments of endometrial cancer on sexual dysfunction. This study will compare two standard of care treatments: HDR (high dose radiation) vaginal brachytherapy 3 fractions of 7 Gy to HDR vaginal brachytherapy 6 fractions of 4Gy for early stage endometrial cancer.

Подробное описание

Patients are randomized to HDR vaginal brachytherapy 7 Gy in 3 fractions prescribed at 5mm. Radiation delivered 4-12 weeks after surgery OR HDR vaginal brachytherapy 4Gy in 6 fractions prescribed at the cylinder surface. Patients have the option to request to decline their randomization and switch to the alternate treatment ARM if they prefer.

Radiation delivered 4-12 weeks after surgery. Participants in all Arms will receive standard vaginal dilator for use after treatment (to promote healing). 3 month, 1 year and 2 year follow up assessments are performed.

Вмешательства

  • Лучевая терапия HDR vaginal brachytherapy
    HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions

Первичные конечные точки

  • Female Sexual Function Index (FSFI) [Срок оценки: 1 year]
  • Preference Option Randomized Design (PORD) [Срок оценки: 1 year]
Вторичные конечные точки (2)
  • Vaginal Length Measurement [Срок оценки: 1 year]
  • Vaginal Length Measurement [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator.
  • Surgery consisted of Total Abdominal or Laparoscopic Hysterectomy and Bilateral Salpingo Oophorectomy (TH-BSO) with or without lymph node dissection.
  • Subject must have FIGO Stage I-II (grade 1-3) pathologically proven (histologic) endometrioid cancer, including all subtypes. Serous, clear cell, and carcinosarcoma histologic pathologies are allowed.
  • Subjects must have no measurable disease after surgery.
  • ECOG Performance Status of 0-2
  • Age ≥ 18 years
  • Subject must have a life expectancy ≥ 12 months

Критерии исключения

  • Disease of more advanced stage (FIGO stage III-IV) or disease for which adjuvant external beam radiation therapy or chemotherapy is indicated
  • Patients with a history of prior pelvic radiation therapy or if additional pelvic radiation therapy is planned
  • Subjects who have not recovered from side effects of agents administered more than 4 weeks prior to the on-study date
  • Subjects that require > 14 weeks between surgery and initiation of radiation therapy on study unless the subject is receiving chemotherapy. Subjects receiving chemotherapy may have radiation therapy initiated within 6 months after surgery.

\* Subjects who do not meet this criteria may still be eligible. The UVA Coordinating Center and Overall Study PI will review each case and inform the site of the approval decision.

  • Subjects who are receiving any investigational agents or have had any investigational agent within the 30 days prior to the on-study date
  • Subject is unable or unwilling to participate in a study-related procedure
  • Pregnant and breastfeeding women are excluded from this study
  • Subject is a prisoner
  • A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy.
  • Subjects with a history of evidence upon physical examination of central nervous system disease including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (stroke), transient ischemic attack, or subarachnoid hemorrhage within six months of study entry

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
Открытое
Основная цель
Лечение

Центры проведения

США · 3 центра
  • University of Maryland Medical Center (UMMC) — Baltimore
  • SUNY Upstate Medical University — Syracuse
  • University of Virginia — Charlottesville

Идентификаторы

NCT: NCT03785288 · 21063

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗