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Intraoperative Radiotherapy in Treating Spinal Metastases
Sponsor: Shanghai Changzheng Hospital
Summary
In order to provide theoretical evidence for the comprehensive and standardized treatment of spinal metastases with pathological fractures and/or spinal cord compression, the investigators conduct this trial to investigate the efficacy and safety of IORT and postoperative SBRT in adjuvant treatment of metastatic spinal tumors after posterior decompression surgery by recruiting patients with spinal metastases who met the inclusion criteria, and randomly divided them into the following treatment cohorts: 1) decompression surgery + IORT (15-20 Gy, 20-50min）; 2) decompression surgery and postoperative SBRT(30Gy, 5 fractions, 3 weeks).
Official title: The Efficacy and Safety of Intraoperative Radiotherapy Vesus Stereotactic Body Radiotherapy in Managing Spinal Metastases: A Prospective, Single-center, Open-label, Non-inferior, Randomized Controlled Trial
Key Details
Gender
All
Age Range
35 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2024-01
Completion Date
2027-01
Last Updated
2023-10-23
Healthy Volunteers
No
Conditions
Interventions
Intraoperative radiotherapy (IORT)
Intraoperative radiotherapy (IORT, 15-20 Gy, 20-50min)
Stereotactic body radiotherapy (SBRT)
postoperative stereotactic body radiotherapy (SBRT, 30Gy, 5 fractions, 3 weeks)
Locations (1)
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China