Recurrent High Grade Glioma Treated by LITT

Официальное название

Randomized Clinical Trial of Efficiency and Safety of Recurrent High Grade Glioma Treated by Laser Interstitial Thermal Therapy

Обзор

This clinical trial aims to investigate the efficiency and safety of laser interstitial thermal therapy (LITT) in recurrent high-grade glioma (rHGG) patients. The main questions it aims to answer are: * The LITT would increase the progression-free survival and overall survival of rHGG patients compared to other treatments. * The LITT is safe and applicable to rHGG patients Participants will be randomized to the intervention group (LITT) or control group at a ratio of 2:1. The intervention group patients will receive LITT. The control group will be treated with any other treatment. The primary outcome of this trial is progression-free survival. The estimated sample size is 135, 90 in the LITT group and 45 in the control group.

Вмешательства

• Устройство LITT
  The patients in the intervention group will receive LITT, other treatments, including systematic therapy and radiology therapy, would be not restricted except the craniotomy of resection before tumor progression or emergency. The patient is supposed to receive LITT post-randomization within 7 days.
• Другое Control
  The patients in the control group will receive the best medical management under guidelines except LITT before tumor progression. Craniotomy will not be restricted,

Первичные конечные точки

• Progression-free survival [Срок оценки: estimate 6 months]

Вторичные конечные точки (4)

• Lesion ablation rate [Срок оценки: within 2 days Post LITT]
• Lesion remaining volume [Срок оценки: within 2 days Post LITT]
• Overall survival [Срок оценки: up to 2 years]
• Karnofsky Performance Status (KPS) shift [Срок оценки: Day 30,Day 90, Day 180]

Критерии участия

Критерии включения

• Aged 18 years old or above;
• Patients with previous pathological diagnosis of 2021 World Health Organization Classification of Central Nervous System Tumors (WHO CNS5) grade 3 or 4 glioma and received standard treatment;
• Meet any of the following:

• Meets the disease progression criteria in the Response Evaluation of Neuro-Oncology (RANO 2.0) criteria;
• At least one image other than T1 contrast indicates progression;
• Pathology shows progression or recurrence;
• Other progress determined by the Clinical Events Committee (CEC);
• All tumor lesions are located supratentorial and the maximum cross-sectional short-axis length in the T1 contrast is ≤30 mm;
• Karnofsky score (KPS) ≥ 60 and the patient can tolerate the intervention;
• The subjects or their agent can understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent form.

Критерии исключения

• Patients may benefit from other treatments or may not benefit from this trial;
• No more than three months since the patient underwent craniotomy;
• MRI contrast cannot be performed;
• Severe coagulation disorder;
• Women who are pregnant, lactating, or planning to become pregnant within 6 months;
• Participated in any other clinical trials of drugs or medical devices within 3 months;
• Combined diseases that may interfere with treatment or prognosis assessment;
• Refuse or unlikely to complete follow-up assessment;
• Other circumstances in which the researcher deems it inappropriate to participate in this clinical trial.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 9 центров

• Beijing Tiantan Hospital — Пекин
• Beijing Tsinghua Changgung Hospital — Пекин
• The First Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• Tongji Hospital — Ухань
• The First Hospital of Jilin University — Changchun
• The Peoples Hospital of Liaoning — Шэньян
• Qilu Hospital — Цзинань
• … и ещё 1 центр

Идентификаторы

NCT: NCT06161610 · REGALITT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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