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Набор скоро начнётся NCT07439172

Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma.

Фаза II С лечением High Grade Gliomas Glioblastoma Astrocytoma Oligodendroglioma

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: Pre-radiation temozolomide..
Кому может быть актуально
Состояния в реестре: High Grade Gliomas, Glioblastoma, Astrocytoma, Oligodendroglioma. Базовые параметры: 18 лет — 80 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
Список центров уточняется — проверьте первичный протокол.
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

A Multi-Centered Evaluation of Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma (HGG): An Approach to Drug Screening That Requires Confirmation

Обзор

Better treatments are needed for high-grade gliomas (HGG), and new ways of treating this disease should be tested. The investigators want to see if giving medicine before radiation works well. After radiation, MRI scans can be harder to understand because radiation changes how the brain looks on the scan. If new medicines are given before radiation, the scans are easier to read. First, the investigators need to find out if giving chemotherapy early works using a drug we already know can treat gliomas. The investigators will start with temozolomide, which is the only chemotherapy approved by the FDA for HGG. If this approach is successful, the investigators can then test new drugs using this screening method.

Вмешательства

  • Препарат Pre-radiation temozolomide.
    Patients will receive 2 cycles of pre-radiation temozolomide (200mg/m\^2). Cycles are 28-days in length. Participants will take temozolomide on days 1-5 of the 28-day cycle.

Первичные конечные точки

  • Response Rate [Срок оценки: Post-operative MRI (day 0) until radiation simulation MRI (day 70).]
Вторичные конечные точки (1)
  • Secondary Outcome [Срок оценки: From start of pre-radiation chemotherapy (day 10) until 2 cycles of pre-radiation temozolomide are complete (day 70)]

Критерии участия

Критерии включения

  • Pathologic diagnosis of high-grade glioma
  • Residual measurable post-operative contrast enhancing tumor
  • Lack of urgency in requiring immediate radiation or chemotherapy (mass effect, mid-line shift, herniation, etc.)
  • Ability to provide informed consent
  • Willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 18-80.
  • Karnofsky Performance Status ³70%.
  • Patients must have the following organ and marrow functions:

Absolute neutrophil count ≥1,500/µL Platelets ≥100,000/µL Hemoglobin ≥ 9 g/dL Total bilirubin £ 1.5 × institutional upper limit of normal (ULN), (except for patients with known Gilbert's syndrome who must have normal direct bilirubin) AST (SGOT)/ALT (SGPT) £ 2.5 × ULN Creatinine £ 1.5 × ULN OR Creatinine clearance ≥ 60 mL/min/1.73m2 APTT/PTT ≤ 1.5 × ULN Sodium ≥ the institutional lower limit of normal

  • Ability to take oral medication and be willing to adhere to the pre-radiation temozolomide regimen
  • For females of reproductive potential: use of highly effective contraception for at least 1 week prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of pr-radiation temozolomide administration
  • For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
  • Patients must have measurable disease as defined by RANO criteria.

Критерии исключения

  • Patients receiving any other investigational agents are ineligible.
  • Patients who had Gliadel wafer or other local therapy placed in the tumor cavity during the tumor resection.
  • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to TMZ are ineligible.
  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible.
  • Pregnant women are excluded from this study because TMZ has potential for teratogenic or abortifacients effects. Breastfeeding should be discontinued if the mother is treated with TMZ.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07439172 · 25-242

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗