Intraoperative Radiotherapy in Treating Spinal Metastases
ConditionSpinal Metastases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-75
SponsorShanghai Changzheng Hospital
About this trial
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).
Eligibility criteria
Qualifiers
Clinical diagnosis of spinal metastases;
Estimated survival time more than 3 months;
The spinal instability neoplastic score (SINS) >12;
The general condition allows to recieve surgery;
Disqualifiers
Clinical diagnosis of primary spinal tumors;
Presence of metastases in central nerve system;
Isolated lesion undergoing en bloc resection;
Mental disorder and/or intellectual dificiency;
Trial design
Treatments tested in this trial
- Intraoperative radiotherapy (IORT)
- Stereotactic body radiotherapy (SBRT)
Treatment groups
132 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov