NCT02512965

Study Comparing Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy (CRT) for Spinal Metastases

A Randomized Phase II/III Study Comparing Stereotactic Body Radiotherapy(SBRT) Versus Conventional Palliative Radiotherapy (CRT) for Patients With Spinal Metastases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if SBRT is better than CRT at controlling pain in the spine 3 months after receiving treatment.

Detailed description

This research is being done because while there is some evidence suggesting that SBRT may improve treatment for patients with spine metastases, more research is needed to determine if it is better than CRT. The first part of the randomized trial (phase II) looked at whether it was possible (feasible) to provide these treatments in cancer centres across Canada, by aiming to recruit 54 participants within 18 months. This part of the study was successfully completed in early 2017. The second component of this study, called a randomized phase III trial, is now underway. It involves recruiting another 124 participants to receive either CRT or SBRT, using the same study procedure as in the feasibility study. We will continue to obtain information about whether SBRT is better than CRT at controlling pain.

Conditions

• Spinal Metastases

Interventions

Type	Name	Description
RADIATION	20 Gy in 5 fractions
RADIATION	Conventional SBRT: 24 Gy in 2 fractions

Timeline

• Start date: 2016-01-04
• Primary completion: 2020-07-21
• Completion: 2021-08-16
• First posted: 2015-07-31
• Last updated: 2024-02-13
• Results posted: 2021-08-16

Locations

22 sites across 2 countries: Australia, Canada