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.)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nu Zhang, Professor
- Phone Number: 13825070717
- Email: zhangnu2@mail.sysu.edu.cn
Study Contact Backup
- Name: Kejun He, Attending
- Phone Number: 15920463410
- Email: mailto:hekejun3@ms.sysu.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The overall survival of enrolled patients was compared with the overall survival reported in the literature
Time Frame: 15 months
|
15 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nu Zhang, Professor, he First Affiliated Hospital of Sun Yat sen University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Neoplasms
- Glioblastoma
- Brain Neoplasms
Other Study ID Numbers
- EA [2024]349
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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