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Идёт набор NCT04181684

LITT Followed by Hypofractionated RT for Recurrent Gliomas

Без фазы С лечением Glioblastoma Brain Tumor Glioma Neoplasms

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: Procedure: LITT, Hypo-Fractionated Radiation Therapy.
Кому может быть актуально
Состояния в реестре: Glioblastoma, Brain Tumor, Glioma, Neoplasms. Базовые параметры: от 22 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 →

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Официальное название

Pilot Study of Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy for Treatment of Recurrent Gliomas.

Обзор

The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with recurrent gliomas.

Подробное описание

Radiation therapy is preferably used as an adjunct to surgery for patients with a newly diagnosed or recurrent glioblastoma. LITT offers an alternative to surgical resection, and due to its minimally invasive nature, does not delay initiating radiation therapy. Another advantage of LITT prior to radiation therapy is the ability to obtain a tissue diagnosis of recurrent tumor prior to initiating radiation therapy.

Вмешательства

  • Устройство Procedure: LITT
    This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.
  • Лучевая терапия Hypo-Fractionated Radiation Therapy
    Treatments will be delivered once daily on consecutive treatment days (typically 5 fractions per week). Radiation therapy simulation is to be performed within 10 days of the LITT procedure.

Первичные конечные точки

  • Adverse Events [Срок оценки: 2 years]
Вторичные конечные точки (6)
  • Progression-free survival at 6 months [Срок оценки: 2 Years]
  • Median progression-free survival [Срок оценки: 2 Years]
  • Median overall survival [Срок оценки: 2 years]
  • 1-year overall survival [Срок оценки: 2 years]
  • Overall response rate [Срок оценки: 2 years]
  • Quality of Life before, during, and after treatment [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • Patients with history of a WHO Grade II-IV glioma with radiographic evidence of recurrent or progressive tumor
  • Patient must have received prior radiation therapy for initial treatment of glioma
  • Patients with any number of recurrences are allowed as long as the patient has not undergone re-irradiation
  • Brain MRI with contrast demonstrates an enhancing tumor ≤ 6 cm in largest diameter within 60 days prior to registration
  • History and physical including neurological exam within 30 days prior to registration
  • Karnofsky performance status ≥ 60% within 30 days prior to registration
  • Age ≥ 22 years old
  • Minimum interval since completion of prior radiation treatment is 8 weeks
  • Patients will only receive re-irradiation if pathology from LITT is consistent with recurrent tumor
  • Patients must have signed an approved informed consent
  • Patients with the potential for pregnancy or impregnating their partner must agree to practice effective contraceptive methods to avoid conception while on study and for 6 months after study completion.
  • Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration.

Критерии исключения

  • Patients that are not surgical candidates for stereotactic biopsy or laser ablation
  • Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:
  • History or presence of serious uncontrolled ventricular or significant arrhythmias.
  • Any of the following within 6 months prior to registration: myocardial infarction, severe/unstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack , pulmonary embolism
  • Infratentorial tumor or evidence of leptomeningeal spread
  • Inability to undergo a MRI
  • Pregnant or breast-feeding women

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

США · 4 центра
  • University of Maryland Greenebaum Cancer Center — Baltimore
  • UCH Kaufman Cancer Center — Bel Air
  • Central Maryland Radiation Oncology — Columbia
  • Baltimore Washington Medical Center — Glen Burnie

Идентификаторы

NCT: NCT04181684 · HP-00088569

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗