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临床试验/NCT06929819
NCT06929819尚未招募不适用

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

First Affiliated Hospital, Sun Yat-Sen University0 个研究点目标入组 200 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
主要终点
The overall survival of enrolled patients was compared with the overall survival reported in the literature

研究概览

简要总结

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.)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18-75 years old, non-pregnant or lactating women
  • •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.

排除标准

  • •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.

研究组 & 干预措施

Intraoperative Radiation Therapy in Malignant Cerebral Tumor

Experimental

干预措施: Intraoperative Radiation Therapy in Malignant Cerebral Tumor (Radiation)

结局指标

主要结局

The overall survival of enrolled patients was compared with the overall survival reported in the literature

时间窗: 15 months

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhang Nu

Discipline Leader of Neurosurgery department, Clinical Professor

First Affiliated Hospital, Sun Yat-Sen University

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