Research on the Safety and Efficacy of Intraoperative Radiation Therapy in Malignant Cerebral Tumor

Обзор

According to the latest national cancer statistics released by the National Cancer Center in February 2022, intracranial tumors account for about 60%-70% of the more than 3.5 million cancer patients, and the morbidity and mortality remain high. Intracranial malignant tumors have become a problem that needs to be solved urgently because of their early recurrence, rapid progression, and short survival, and intracranial malignant tumors include high-grade gliomas, metastases, lymphomas, etc. Glioblastoma (GB) is the most common primary malignancy in the adult central nervous system, accounting for about 57% of all gliomas and 48% of all primary weighted nervous system malignancies. At present, the standard treatment for glioblastoma is mainly surgical treatment, supplemented by postoperative concurrent chemoradiotherapy and adjuvant chemotherapy, but the prognosis of patients is still poor, with a one-year survival rate of 40.6%, a five-year survival rate of only 5.6%, and an average survival time of 12-15 months. For patients diagnosed with intracranial malignancies (including high-grade glioma, metastases, lymphoma, etc.), multimodal image-guided microsurgery combined with postoperative chemoradiotherapy recommended by the guidelines, and intraoperative radiotherapy with tumor bed radiation therapy to achieve targeted and precise tumor treatment, thereby improving the prognosis of patients (including progression-free survival and median overall survival, etc.)

Вмешательства

• Лучевая терапия Intraoperative Radiation Therapy in Malignant Cerebral Tumor
  This technique can fully expose the tumor bed during the operation, and pull the brain tissue around the tumor under the microscope to de-radiation, so as to exceed the total dose level of standard conformal conventional external radiation therapy (EBRT), maximize the radiobiological effect of a single high-dose irradiation, and deliver precise radiation to the tumor bed, while minimizing the radiation dose of peripheral nerve tissue. This technique is also a good choice for patients with orthot

Первичные конечные точки

• The overall survival of enrolled patients was compared with the overall survival reported in the literature [Срок оценки: 15 months]

Критерии участия

Критерии включения

• 18-75 years old, non-pregnant or lactating women
• KPS ≥60
• MRI and CT of the brain with contrast should be considered for diagnosis of high-grade glioma or other malignant brain tumors
• No other underlying diseases that affect survival time, follow-up or quality of life, and no other serious organic lesions
• Not receive radiotherapy, chemotherapy and other treatment methods for intracranial lesions in the past;
• Tumor located supratentorium, and the position should ensure that the tumor resection volume is more than 90%;
• The required dose of standard radiotherapy exceeds normal tissue tolerance
• No related contraindications such as intraoperative radiotherapy and craniotomy.

Критерии исключения

• Refuse to undergo craniotomy or radiation therapy;
• The postoperative paraffin pathological results were not high-grade gliomas or other cranial malignant tumors;
• Refuse to participate in the clinical trial after informed consent without the above exclusion criteria.

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: NCT06929819 · EA [2024]349

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗