NCT06120426

En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.

En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor-A Multi-center, Prospective, Randomized, Controlled Study.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 182 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to explore the impact of En bloc surgery and separation surgery combined with radiation therapy on the prognosis and survival of patients with spinal oligometastatic cancer, describe the clinical results, and optimize future treatment goals

Detailed description

Patients with oligometastatic diseases have been shown to have better prognosis than those with multiple metastatic diseases, and some patients have achieved long-term survival, thus being considered to benefit from more aggressive treatment. Active local treatment, including surgery and/or targeted radiotherapy, such as Stereotactic Radiosurgery (SRS) and Stereotactic body radiotherapy (SBRT), can be performed before or after systemic treatment. For both primary and oligometastatic tumors, radical treatment should be considered in order to achieve better survival and prognosis. The current research has explored the different effects of oligometastatic disease status on the prognosis of various cancers. However, there is currently no clear clinical or experimental confirmation of the impact on the survival and treatment outcomes of patients with oligometastatic spinal cancer. The purpose of this clinical trial is to explore the impact of En bloc hand surgery and separation surgery combined with radiotherapy on the prognosis and survival of patients with oligometastatic spinal cancer, Describe clinical outcomes and optimize future treatment goals

Conditions

• Spinal Metastases
• Spinal Tumor
• Radiotherapy
• Malignant Bone Tumor
• Surgery

Interventions

Type	Name	Description
PROCEDURE	total en bloc spondylectomy	Total enbloc resection (TES) is one of the most challenging surgeries in spinal surgery and a classic surgical method. It not only relieve spinal cord compression and delays tumor recurrence, but also prolongs patient survival, significantly reduces hand surgery trauma, and improves surgical safety. However, for cases with extensive tumor invasion, methods such as separation surgery should be used to relieve spinal cord nerve compression, rebuild spinal stability, and provide conditions for postoperative radiotherapy.

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-07-01
• Completion: 2027-07-01
• First posted: 2023-11-07
• Last updated: 2023-11-13

Locations

1 site across 1 country: China