NCT06092255

A Study of SVZ Irradiation With Postoperative Radiotherapy in Patients With GBM.

A Prospective Phase I/II Clinical Study of SVZ Irradiation With Postoperative Radiotherapy in Patients With GBM.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Jiangsu Cancer Institute & Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II clinical trial is intended to investigate the efficacy and safety of SVZ irradiation with postoperative radiotherapy in patients with GBM.

Detailed description

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.

Conditions

• GBM

Interventions

Type	Name	Description
RADIATION	Postoperative radiotherapy for SVZ	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.

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-12-30
• Completion: 2025-12-30
• First posted: 2023-10-23
• Last updated: 2023-10-23

Locations

1 site across 1 country: China