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Идёт набор NCT06297512

Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM).

Фаза II С лечением Glioblastoma

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: Radiotherapy, Temozolomide, Doxorubicin.
Кому может быть актуально
Состояния в реестре: Glioblastoma. Базовые параметры: 3 лет — 30 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
Италия
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

Interventional, Single-arm, Open-label Open-label, Phase II Trial to Evaluate the Role of Anthracycline Infusion After Radio Therapy (RT) in Pediatric and Young Adults With Glioblastoma (pGBM).

Обзор

Glioblastoma (GBM) and diffuse intrinsic bridge gliomas (DIPG) only the most aggressive forms of cancer, and their prognosis remains bleak. Currently, the standard of treatment is TMZ concomitant with radiotherapy, and, at the end of combined treatment, as adjuvant therapy. In vitro and in vivo experimental studies have suggested that anthracyclines are effective antineoplastics for the treatment of gliomas. In patients with solid tumors treated with anthracyclines, continuous infusion administration compared with bolus administration has been shown to provide a better safety profile especially with regard to cardiotoxicity. Based on this evidence, this study aims to evaluate the safety and antitumor activity of combined treatment with Dox, WBRT (whole body radiotherapy), and TMZ in pediatric and young adult patients affected by GMB

Вмешательства

  • Препарат Radiotherapy, Temozolomide, Doxorubicin
    Radiation treatment Concomitant TMZ: 75mg/m2/day per OS for 7 days per week, from the first day of radiotherapy to the last (maximum cumulative dose 3150mg/m2), with possibility of earlier initiation on clinician's judgment. After 1 month (4-5 weeks ± 7 days) from the end of RT/TMZ treatment they will receive: Adjuvant TMZ: 2 cycles at increasing doses (150-180 mg/m2) per OS for 5 consecutive days 28 days apart After 3 months (12 weeks ± 7 days) from the end of RT/TMZ treatment they will rece

Первичные конечные точки

  • Evaluation prolonged Dox [Срок оценки: through study completion, an average of 1 year]
  • Percentage of Withdrawal from the study rate [Срок оценки: through study completion, an average of 1 year]
  • Percentage of SAEs [Срок оценки: through study completion, an average of 1 year]
  • Mortality rate [Срок оценки: through study completion, an average of 1 year]
  • Early discontinuation of dox treatment rate [Срок оценки: through study completion, an average of 1 year]
Вторичные конечные точки (1)
  • Event-free survival (EFS), disease progression (PFS), and overall survival (OS) [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • Patients with histological-molecular diagnosis according to WHO 2016 classification: IDH-wildtype glioblastoma (9440/3), giant cell glioblastoma (9441/3), gliosarcoma (9442/3), epithelioid glioblastoma (9440/3), IDH-mutated glioblastoma (9445/3), glioblastoma NOS (9440/3), diffuse astrocytoma (9400/3), diffuse midline glioma H3 K27M mutated, including multifocal, metastatic or gliomatosis cerebri pictures of first diagnosis Not previously treated (with chemo and radiotherapy) or treated only surgically (total, near partial, partial, biopsy).
  • Males and females between the ages of 3 and 30 years old
  • Life expectancy ≥ 12 months
  • karnofsky/Lansky ≥ 80 %
  • Adequate hematologic function: Absolute leukocyte count ≥ 2.0 x 109/l, Hemoglobin ≥ 10 g/dl, Platelet count ≥ 50 x 109/l
  • Adequate liver function: Total bilirubin ≤ 2.5 x ULN, ALT/AST ≤ 5.0 x ULN
  • Adequate renal function:Serum creatinine ≤ 1.5 x ULN
  • Written informed consent from the patient, parents or legal guardians
  • Patient's willingness during treatment and ability to comply with the protocol

Критерии исключения

  • Evidence of any other serious disease or condition that is a contraindication to study therapy (e.g. severe mental retardation, severe cerebral palsy, severe syndromes congenital syndromes, heart disease)
  • Performance of a course of 1st-line chemotherapy at the same time as study initiation
  • Concurrent participation in other research projects
  • Pregnancy or lactation status
  • Use of inappropriate contraceptive methods

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

Италия · 1 центр
  • Meyer Children's Hospital IRCCS — Florence

Идентификаторы

NCT: NCT06297512 · pGBM-WBRT/DOX2020

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗