NCT05808998

A Single-center Observational Clinical Trial of Stereotactic Radiotherapy on Metastatic Spinal Tumors Using TomoTherapy

A Clinical Trial of Stereotactic Radiotherapy on Spinal Metastasis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 45 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A single-center observational clinical trial will be performed for metastatic spinal tumors by stereotactic radiotherapy using TomoTherapy. In this study, we will explore the local control rate (LCR), disease-free progression time (PFS), overall survival time (OS), and pain relief in patients with spinal metastasis, so as to provide a basis for developing relevant guidelines or consensus.

Detailed description

In this observational single-arm study, a total of 45 patients with metastatic spinal tumors will be enrolled. The patients were aged between 18 and 75 years old. And all the subjects should meet the inclusion criteria and sign the informed consent. Meanwhile, the patients' medical history characteristics, including gender, age, imaging data (X-ray, CT, MRI, or PET-CT, etc.), primary tumor type, pathological type, previous treatment, previous disease history, tumor markers and bone metabolism indexes were collected and recorded on the CRF. The metastatic spinal tumors by stereotactic radiotherapy(SBRT) using TomoTherapy. The adiotherapy dose is 6Gy×5Fx, 5Gy×5Fx or 4Gy×5Fx according to the irradiation site. Treatment should be interrupted if there is severe bone marrow suppression, vertebral compression fracture, or radiation myelitis. The adjacentnormal tissue constrains refer to the UK SABR Consortium Guidelines (2022 version). Follow-up was performed 1 month after radiotherapy, thereafter every 3 months for 1-4 years. The parameters includ blood routine, liver and kidney function, bleeding and coagulation function, bone metabolism index, tumor markers, bone metastasis imaging examination. Tumor response will refer to the Cancer Response Criteria and Bone Metastases: RECIST 1.1, MDA and PERCIST.

Conditions

• Spinal Bone Metastases
• Radiation Therapy

Interventions

Type	Name	Description
RADIATION	Stereotactic body radiotherapy	Stereotactic body radiotherapy using TomoTherapy

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2023-04-12
• Last updated: 2023-04-12