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

NCT ID: NCT06929819

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2030-05-31

Brief Summary

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.)

Conditions

Glioblastoma; Brain Tumor, Primary; Brain Tumor - Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intraoperative Radiation Therapy in Malignant Cerebral Tumor

Group Type: EXPERIMENTAL

Intraoperative Radiation Therapy in Malignant Cerebral Tumor

Intervention Type: RADIATION

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 orthotopic recurrent tumors who can no longer tolerate one more EBRT. Intraoperative radiotherapy technology can reduce the chance of postoperative tumor recurrence and improve the survival and prognosis of patients by providing a higher effective total dose to the tumor bed, while promoting dose escalation without significantly increasing the occurrence of complications in normal tissues, and improving the local control rate.

Interventions

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 orthotopic recurrent tumors who can no longer tolerate one more EBRT. Intraoperative radiotherapy technology can reduce the chance of postoperative tumor recurrence and improve the survival and prognosis of patients by providing a higher effective total dose to the tumor bed, while promoting dose escalation without significantly increasing the occurrence of complications in normal tissues, and improving the local control rate.

Intervention Type: RADIATION

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhang Nu

Discipline Leader of Neurosurgery department, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nu Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

he First Affiliated Hospital of Sun Yat sen University

Central Contacts

Nu Zhang, Professor

Role: CONTACT

zhangnu2@mail.sysu.edu.cn

13825070717

Kejun He, Attending

Role: CONTACT

mailto:hekejun3@ms.sysu.edu.cn

15920463410

Other Identifiers

EA [2024]349

Identifier Type: -

Identifier Source: org_study_id