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

NCT06929819 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-04-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Nu Zhang, Professor · he First Affiliated Hospital of Sun Yat sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-05-31
Completion
2030-05-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06929819 on ClinicalTrials.gov