Clinical Trials Logo

Clinical Trial 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).


Clinical Trial Description

Spine is the most common metastatic site for advanced malignancies, accounting for about 70% of all patients with bone metastasis. Approximately 40% -70% of patients with advanced cancer eventually develop spinal metastases. Spinal metastases require multidisciplinary treatments, and surgical decompression surgery is the preferred treatment in managing spinal metastases with bone related events, especially those with spinal cord compression. The purpose of decompression surgery is to directly relieve nerve compression, alleviate pain, rebuild spinal stability, and reduce tumor burden, which improves the quality of life, and extend the life span indirectly. At the same time, radiotherapy is also an indispensable treatment for spinal metastases after surgical decompression. The purpose of radiotherapy is to remove residual tumor lesions, alleviate pain, and prevent further pathological fractures. Recent years have witnessed the rapid development of stereotactic bone radiotherapy (SBRT). As reported, SBRT can not only increase the radiation dose at the tumor site, but also reduce radiation damage to the spinal cord and surrounding normal tissues, which is the preferred adjuvant treatment for patients with metastatic spinal tumors. However, SBRT has the several risks, including radiation myelitis, delayed vertebral pathological fractures, local skin allergies, radiotherapy side effects in the esophagus and lungs, and duodenal perforation. Moreover, stereotactic radiotherapy technology has higher costs compared to traditional external beam radiotherapy. Recently, the application of intraoperative radiotherapy (IORT) can effectively reduce the direct radiation for surrounding normal tissues and maximally eliminate the residual tumor cells. The advantages of IORT include: ① immediate reduction of the possibility of tumor cell expansion after surgery; ② Safe direct radiation and effective protection of normal tissues beyond the radiation depth; ③ To effectively protect adjacent normal tissues, light-limiting tubes with different diameters can be selected based on the size and range of tumor; ④ Shortening treatment course with lower costs and better compliance; ⑤ Slight systemic side effects and bone marrow suppression. To the knowledge, no research focuses on the efficacy of IORT and SBRT in the adjuvant treatment of spinal metastases. Therefore, 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06093854
Study type Interventional
Source Shanghai Changzheng Hospital
Contact
Status Not yet recruiting
Phase N/A
Start date January 2024
Completion date January 2027

See also
  Status Clinical Trial Phase
Completed NCT01347307 - Stereotactic Body Radiotherapy for Spine Tumors N/A
Terminated NCT00593320 - Stereotactic Radiosurgery (SRS) for Spine Metastases N/A
Recruiting NCT05575323 - Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases N/A
Completed NCT02987153 - Kypho-Intra Operative Radiation Therapy (IORT) for Localized Spine Metastasis, Phase I/II Study N/A
Recruiting NCT03363685 - Verification of Novel Survival Prediction Algorithm for Patients With NSCLC Spinal Metastasis
Terminated NCT02407795 - Conventional With Stereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases N/A
Completed NCT01365715 - Preoperative Embolization in Surgical Treatment of Spinal Metastases. N/A
Recruiting NCT04863612 - SBRT in the Management of Solid Spinal Metastases
Recruiting NCT04242589 - Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions Phase 2
Recruiting NCT01849510 - Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost Phase 2
Not yet recruiting NCT06244264 - The Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis N/A
Not yet recruiting NCT06220071 - Multicentric European Study In Patients With Vertebral Metastases
Completed NCT01290562 - Stereotactic Body Radiotherapy (SBRT) for Spinal/Para-Spinal Metastases (Spine SBRT) Phase 2
Recruiting NCT06120426 - En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.
Completed NCT03224650 - Validation of Novel Predictive Score for Patients With Spinal Metastases
Completed NCT02512965 - Study Comparing Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy (CRT) for Spinal Metastases N/A
Completed NCT02364115 - Randomized Trial Comparing Conventional Radiotherapy With Stereotactic Radiotherapy in Patients With Bone Metastases - VERTICAL Study N/A
Recruiting NCT03398915 - The European Robotic Spinal Instrumentation (EUROSPIN) Study
Not yet recruiting NCT05173467 - Robot-assisted Invasion-controlled Surgery Versus Traditional-open Surgery Against Metastatic Spinal Tumor N/A
Recruiting NCT04248543 - Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases N/A