Intraoperative Radiotherapy in Treating Spinal Metastases

Launched by SHANGHAI CHANGZHENG HOSPITAL · Oct 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of two different treatments for patients with spinal metastases, which are cancerous tumors that have spread to the spine. The goal is to see how well intraoperative radiotherapy (IORT) and postoperative stereotactic body radiation therapy (SBRT) can help patients after they have had surgery to relieve pressure on their spinal cord. Participants will be randomly assigned to receive either IORT during their surgery or SBRT after their surgery.

To be eligible for this trial, participants must have a diagnosis of spinal metastases, expect to live for at least three more months, and have certain conditions that allow for surgery. They should also have significant spinal issues that could lead to instability or compression of the spinal cord. It’s important for potential participants to understand that they will need to sign a consent form agreeing to take part in the study and may have follow-up appointments to monitor their health. The trial is not yet recruiting participants, but it aims to provide valuable information that could improve treatment options for patients with spinal metastases in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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;
• • Single or multiple metastatic lesions with only one site presenting epidural spinal cord compression;
• • signed informed consent.
• Exclusion Criteria:
• • 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;
• • Refusing to accept follow-up;
• • without signing informed consent.