Tumor Treating Fields (TTF) in Combination with Stereotactic Radiosurgery(SRS) for Brain Metastases from Non-small Cell Lung Cancer.

Официальное название

Tumor Treating Fields (TTF) in Combination with Stereotactic Radiosurgery(SRS) for Brain Metastases from Non-small Cell Lung Cancer: a Randomized, Controlled, Open-label Study.

Обзор

This is a randomized, controlled, open-label, phase III trials. The main purpose of this study is to evaluate the effectiveness and safety of tumor treating felds (TTF) combined with stereotactic radiosurgery (SRS) in the treatment of brain metastases from non-small cell lung cancer (NSCLC) .

Вмешательства

• Устройство Tumor treating felds (TTF)
  Tumor Treating Fields will be administered continuously with a planned ≥ 18 h per day.
• Другое Best Standard of Care
  Patients will be treated with the best known standard of care for NSCLC brain metastasis and undergo SRS alone.

Первичные конечные точки

• Intracranial tumor progression-free survival (iPFS) [Срок оценки: 3 years]

Вторичные конечные точки (7)

• Overall Survival (OS) [Срок оценки: 3 years]
• Objective response rate (ORR) [Срок оценки: 3 years]
• Time to neurocognitive failure [Срок оценки: 3 years]
• Rate of intracranial progression at 2, 4, 6, 8, 10, 12 months [Срок оценки: 3 years]
• Neurocognitive failure-free survival [Срок оценки: 3 years]
• Rate of decline in cognitive function [Срок оценки: 3 years]
• Number of participants with adverse events (AEs) [Срок оценки: 3 years]

Критерии участия

Критерии включения

• The age of the subject was between 18 and 75 years old (inclusive), regardless of gender;
• The predicted survival time was ≥3 months;
• Newly diagnosed with NSCLC brain metastasis;
• MRI imaging showed 1-10 unresectable brain metastases;
• Karnofsky performance status (KPS) score ≥70;
• Able to operate the TTF independently or with the help of a caregiver;
• Subjects of childbearing potential had to agree to use effective contraception for the duration of the trial;
• Voluntarily signed the informed consent form.

Критерии исключения

• Positive driver genes;
• Recurrent brain metastasis of NSCLC;
• Suffering from severe cerebral edema;
• Leptomeningeal metastases;
• Participants had to meet certain criteria for bone marrow, liver and kidney function before enrollment, and were not eligible if they had any of the following:

• platelet count < 100×103/μL;
• absolute neutrophil count < 1.5×103/μL;

d. AST or ALT exceeding 2.5 times the upper limit of normal; c.Total bilirubin more than 1.5 times the upper limit of the normal range; d.Severe renal impairment (serum creatinine >1.7 mg/dL, or >150 μmol/L);

• There were infection, ulcer and unhealed wound in the skin where the electrode was applied；
• Patients allergic to conductive hydrogels or medical adhesives;
• Those who are pregnant or preparing to become pregnant or who are breastfeeding;
• Patients with poor compliance, as judged by the investigator, or other factors considered by the investigator to be not suitable for the study.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06716775 · HL-10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗