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

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.)

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Key information

Conditions

Glioblastoma Astrocytoma Brain Diseases Brain Neoplasms Brain Tumor - Metastatic Brain Tumor, Primary Central Nervous System Diseases Central Nervous System Neoplasms Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intraoperative Radiation Therapy in Malignant Cerebral Tumor

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.

Primary outcomes

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

Time frame: 15 months

Study contacts

Contact information is provided by the study sponsor or research team.

Kejun He, Attending

CONTACT

mailto:[email protected]

15920463410

Nu Zhang, Professor

CONTACT

[email protected]

13825070717

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2030
First posted: Apr 16, 2025
Registry last updated: Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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