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Intraoperative Radiotherapy in Treating Spinal Metastases

NCT06093854 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2023-10-23

No results posted yet for this study

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).

Conditions

  • Spinal Metastases

Interventions

RADIATION

Intraoperative radiotherapy (IORT)

Intraoperative radiotherapy (IORT, 15-20 Gy, 20-50min)

RADIATION

Stereotactic body radiotherapy (SBRT)

postoperative stereotactic body radiotherapy (SBRT, 30Gy, 5 fractions, 3 weeks)

Sponsors & Collaborators

  • Shanghai Changzheng Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06093854 on ClinicalTrials.gov