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

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

Study Purpose

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.)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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; - Refuse to participate in the clinical trial after informed consent without the above exclusion criteria.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06929819
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	First Affiliated Hospital, Sun Yat-Sen University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Nu Zhang, Professor
Principal Investigator Affiliation	he First Affiliated Hospital of Sun Yat sen University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma, Brain Tumor, Primary, Brain Tumor - Metastatic

Arms & Interventions

Arms

Experimental: Intraoperative Radiation Therapy in Malignant Cerebral Tumor

Interventions

Radiation: - 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.