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This phase I/II clinical trial is intended to investigate the efficacy and safety of SVZ irradiation with postoperative radiotherapy in patients with GBM.
This study is a single-center, single-arm, phase I/II clinical study. It is intended to include treatment-naïve patients with histologically or cytologically confirmed glioblastoma who have received only radical surgical treatment according to the investigator's assessment. After signing the informed consent, the patient will be selected to meet the inclusion criteria and will receive postoperative adjuvant radiotherapy combined with temozolomide chemotherapy, followed by 6 cycles of temozolomide maintenance therapy. During the follow-up process, patients included in the study can withdraw from this study if they are judged by MRI examination to have disease progression, unacceptable toxic reactions occur, or the subject decides to withdraw from the study. The subsequent specific treatment plan will be discussed with the MDT and fully discussed with the patient and family members. Implement after communication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preventive radiotherapy irradiation SVZ group | Experimental | GBM patients who met the inclusion criteria received radiotherapy range and dose based on the EORTC outline principles. The ipsilateral and contralateral SVZ areas received 56Gy and 40Gy respectively, with a fractionated dose of 2Gy. Concurrent chemotherapy with temozolomide and six cycles of adjuvant temozolomide chemotherapy were performed at the same time as radiotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postoperative radiotherapy for SVZ | Radiation | GBM patients who met the inclusion criteria received radiotherapy range and dose based on the EORTC outline principles. The ipsilateral and contralateral SVZ areas received 56Gy and 40Gy respectively, with a fractionated dose of 2Gy. Concurrent chemotherapy with temozolomide and six cycles of adjuvant temozolomide chemotherapy were performed at the same time as radiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free survival (PFS), defined as the time from treatment to progression or death, whichever occurs first; | 12 monnths |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival (OS), defined as the time from treatment to death. | 12 monnths |
| Safety evaluation | Adverse events were assessed according to NCI CTCAE (version 5.0) |
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Inclusion Criteria:
1. Patients voluntarily join this study, have the ability to understand and are willing to sign the informed consent form.
2. Aged between 18-70 years old (inclusive). 3. Newly diagnosed glioblastoma confirmed by pathology. 4. The patient must have undergone maximum surgical resection and start radiotherapy within 12 weeks after surgery.
5. MRI shows that the patient's SVZ area is involved or the distance between the tumor and the SVZ area is less than or equal to 1cm.
6. No previous brain irradiation. 7. Women of childbearing age have a negative urine test or serum pregnancy test and are contraceptive during the treatment period.
8. The ECOG performance status assessed within 7 days before the study intervention is 0-1 points.
9. Have sufficient organ function, and the subject needs to meet the following laboratory indicators:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lining Guo | Contact | 15182456673 | guolining2023@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lijun Wang | Jiangsu Cancer Institute & Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lining Guo | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| 12 months |