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

Sun Yat-sen University

Status

Not yet enrolling

Conditions

Glioblastoma

Brain Tumor, Primary

Brain Tumor - Metastatic

Treatments

Radiation: Intraoperative Radiation Therapy in Malignant Cerebral Tumor

Study type

Interventional

Funder types

Other

Identifiers

NCT06929819

EA [2024]349

Details and patient eligibility

About

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.)

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.