GlioblastomaNCT06929819
Research on the Safety and Efficacy of Intraoperative Radiation Therapy in Malignant Cerebral Tumor
A study testing Intraoperative Radiation Therapy in Malignant Cerebral Tumor in people with Glioblastoma and Brain Tumor, Primary, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma, Brain Tumor, Primary, Brain Tumor - Metastatic
- What is being tested?
- Intraoperative Radiation Therapy in Malignant Cerebral Tumor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Intraoperative Radiation Therapy in Malignant Cerebral Tumor
- Keywords
- Brain Tumor, Intraoperative Radiation Therapy
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Radiation Therapy in Malignant Cerebral TumorRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Radiation Therapy in Malignant Cerebral Tumor | Experimental | Not described Receives: Radiation: Intraoperative Radiation Therapy in Malignant Cerebral Tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall survival of enrolled patients was compared with the overall survival reported in the literature
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This trial is a single-arm study, and patients who are willing to undergo IORT are selected for inclusion in the study after initial screening, and intraoperative radiotherapy of an appropriate dose is given immediately after tumor resection during surgery, followed by postoperative adjuvant therapy according to disease guidelines. The time of recurrence and/or death and the time of adverse events were recorded. This trial is a superiority study and the control is currently the world-recognized median OS or PFS.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Nu, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Nu Zhang, Professor, Principal investigator, he First Affiliated Hospital of Sun Yat sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929819
- Sponsor's protocol ID
- EA [2024]349
- Status last verified
- Apr 2025
- First submitted
- 9 Sep 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Safety and Efficacy of Intraoperative Radiation Therapy in Malignant Cerebral Tumor
- ClinicalTrials.gov ID
- NCT06929819
- Acronym / sponsor ID
- EA [2024]349
- Conditions
- Glioblastoma, Brain Tumor, Primary, Brain Tumor - Metastatic
- Keywords
- Brain Tumor, Intraoperative Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This trial is a single-arm study, and patients who are willing to undergo IORT are selected for inclusion in the study after initial screening, and intraoperative radiotherapy of an appropriate dose is given immediately after tumor resection during surgery, followed by postoperative adjuvant therapy according to disease guidelines. The time of recurrence and/or death and the time of adverse events were recorded. This trial is a superiority study and the control is currently the world-recognized median OS or PFS.
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Radiation Therapy in Malignant Cerebral Tumor | Experimental | Radiation: Intraoperative Radiation Therapy in Malignant Cerebral Tumor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative Radiation Therapy in Malignant Cerebral TumorThis 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. | Radiation | Intraoperative Radiation Therapy in Malignant Cerebral Tumor |
Primary outcome
The overall survival of enrolled patients was compared with the overall survival reported in the literature
Time frame: 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nu Zhang, Professor principal investigator
he First Affiliated Hospital of Sun Yat sen University
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Radiation Therapy in Malignant Cerebral Tumor in people with Glioblastoma and Brain Tumor, Primary, run by First Affiliated Hospital, Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nu Zhang, Professor (13825070717, zhangnu2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall survival of enrolled patients was compared with the overall survival reported in the literature (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.